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NDC properties for "ampicillin (as ampicillin sodium) 1 GM / sulbactam (as sulbactam sodium) 0.5 GM Injection" (RxCUI 1659592)

About this data

The tables show NDC propoerties for ampicillin (as ampicillin sodium) 1 GM / sulbactam (as sulbactam sodium) 0.5 GM Injection with the RxCUI 1659592

This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product

Details for ampicillin (as ampicillin sodium) 1 GM / sulbactam (as sulbactam sodium) 0.5 GM Injection (RxCUI 1659592)

ANDAANDA065176
ANDAANDA065222
ANDAANDA065310
ANDAANDA065406
ANDAANDA090340
ANDAANDA090349
ANDAANDA090579
ANDAANDA201024
ANDAANDA201406
MMSL_CODEBD1345
MMSL_CODECD1345
RxCUI1659592
SNOMEDCT370418003
SPL_SET_ID006f9a3f-b4e3-4aa5-ac65-6cc3d3e2582d
SPL_SET_ID16fdfdb9-9e26-48d0-8838-570d30c8e897
SPL_SET_ID1e5004f1-e79e-4e0b-9f3f-25f6bbc15255
SPL_SET_ID6ae2c4a1-f704-4642-bbdd-f69a9ef07605
SPL_SET_ID7161f386-6373-4db5-8dfd-d7ddf38ec2f1
SPL_SET_ID71b45af0-7363-4c93-8106-0a2220e62d9e
SPL_SET_ID942ea2a7-8a1b-405e-a802-2ff0debc388b
SPL_SET_ID9a722de6-9dc0-4fb9-b63a-225385aa3314
SPL_SET_IDa67ae347-487d-4751-a841-b321e81db26f
SPL_SET_IDac6f8158-9d7e-4b99-af3c-0407c5287b57
SPL_SET_IDadc92303-b62b-41c8-becf-9c3a4e8c3a6b
SPL_SET_IDbb78b01f-b235-4a3e-b3d2-24543d3fd56c
SPL_SET_IDd3026cc0-95d8-44cf-be47-b5ebb8fd4568
SPL_SET_IDd4e9ca30-7af3-42ec-e053-2995a90afe1f
SPL_SET_IDdc374fa4-350b-425d-a7db-7099fdc64cf1
SPL_SET_IDe6cf14a8-3ed9-4a7a-ba69-be0b794cbdc4
SPL_SET_IDf8e534d8-5bb8-47c4-a11e-ec67f0609d1d
VUID4008598
Prescribable Synonymampicillin / sulbactam 1.5 GM Injection
RXNAV_STRampicillin 1000 MG / sulbactam 500 MG Injection
RxNorm Nameampicillin 1000 MG / sulbactam 500 MG Injection
RxNorm Synonymampicillin (as ampicillin sodium) 1 GM / sulbactam (as sulbactam sodium) 0.5 GM Injection
RxNorm Synonymampicillin 1 GM / sulbactam 0.5 GM Injection
Related queriesInteractions (for RxCUI 1659592)



NDC Properties

NDC Item 00409268901

NDC 90409-2689
NDC 100409-2689-01
NDC Item00409268901
Packaging10 VIAL in 1 TRAY (0409-2689-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0409-2689-21)
ANDAANDA065310
FDA SPL set id806154
LabelerHospira, Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-07-25
Marketing statusACTIVE
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268921

NDC 90409-2689
NDC 100409-2689-21
NDC Item00409268921
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268949

NDC 90409-2689
NDC 100409-2689-49
NDC Item00409268949
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00641611601

NDC 90641-6116
NDC 100641-6116-01
NDC Item00641611601
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611610

NDC 90641-6116
NDC 100641-6116-10
NDC Item00641611610
Packaging10 VIAL in 1 CARTON (0641-6116-10) / 1.5 g in 1 VIAL (0641-6116-01)
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611901

NDC 90641-6119
NDC 100641-6119-01
NDC Item00641611901
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641611910

NDC 90641-6119
NDC 100641-6119-10
NDC Item00641611910
Packaging10 VIAL in 1 CARTON (0641-6119-10) / 1.5 g in 1 VIAL (0641-6119-01)
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641612201

NDC 90641-6122
NDC 100641-6122-01
NDC Item00641612201
Packaging4 mL in 1 VIAL
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00641612210

NDC 90641-6122
NDC 100641-6122-10
NDC Item00641612210
Packaging10 VIAL in 1 CARTON (0641-6122-10) / 4 mL in 1 VIAL (0641-6122-01)
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00781303270

NDC 90781-3032
NDC 100781-3032-70
NDC Item00781303270
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 00781303295

NDC 90781-3032
NDC 100781-3032-95
NDC Item00781303295
Packaging10 VIAL in 1 CARTON (0781-3032-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-3032-70)
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 25021014220

NDC 925021-142
NDC 1025021-142-20
NDC Item25021014220
Packaging10 VIAL in 1 CARTON (25021-142-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065406
FDA SPL set id612973
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-06-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 25021-142

NDC Item 25021018620

NDC 925021-186
NDC 1025021-186-20
NDC Item25021018620
Packaging10 VIAL in 1 CARTON (25021-186-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090579
FDA SPL set id549185
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-03-31
Marketing effective time low2017-08-15
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 25021-186

NDC Item 44567021010

NDC 944567-210
NDC 1044567-210-10
NDC Item44567021010
Packaging10 VIAL in 1 CARTON (44567-210-10) / 10 mL in 1 VIAL
ANDAANDA065176
FDA SPL set id803837
LabelerWG Critical Care, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 44567-210

NDC Item 55150011601

NDC 955150-116
NDC 1055150-116-01
NDC Item55150011601
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011610

NDC 955150-116
NDC 1055150-116-10
NDC Item55150011610
Packaging10 VIAL in 1 CARTON (55150-116-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011620

NDC 955150-116
NDC 1055150-116-20
NDC Item55150011620
Packaging10 VIAL in 1 CARTON (55150-116-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150017899

NDC 955150-178
NDC 1055150-178-99
NDC Item55150017899
Packaging10 BOTTLE in 1 BOX (55150-178-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE
ANDAANDA090340
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-09-13
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-178

NDC Item 63323036820

NDC 963323-368
NDC 1063323-368-20
NDC Item63323036820
Packaging10 VIAL in 1 CARTON (63323-368-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065222
FDA SPL set id460623
LabelerFresenius Kabi USA, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2016-05-05
Marketing effective time low2005-11-29
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 63323-368

NDC Item 66794020602

NDC 966794-206
NDC 1066794-206-02
NDC Item66794020602
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794020641

NDC 966794-206
NDC 1066794-206-41
NDC Item66794020641
Packaging10 VIAL in 1 CARTON (66794-206-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-206-02)
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794024102

NDC 966794-241
NDC 1066794-241-02
NDC Item66794024102
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 66794024141

NDC 966794-241
NDC 1066794-241-41
NDC Item66794024141
Packaging10 VIAL in 1 CARTON (66794-241-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-241-02)
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 67457034810

NDC 967457-348
NDC 1067457-348-10
NDC Item67457034810
Packaging10 VIAL in 1 CARTON (67457-348-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67457034815

NDC 967457-348
NDC 1067457-348-15
NDC Item67457034815
Packaging1 VIAL in 1 CARTON (67457-348-15) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67850013000

NDC 967850-130
NDC 1067850-130-00
NDC Item67850013000
Packaging1 in 1 VIAL, GLASS
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 67850013010

NDC 967850-130
NDC 1067850-130-10
NDC Item67850013010
Packaging10 VIAL, GLASS in 1 CARTON (67850-130-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (67850-130-00)
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 70594008101

NDC 970594-081
NDC 1070594-081-01
NDC Item70594008101
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 70594008102

NDC 970594-081
NDC 1070594-081-02
NDC Item70594008102
Packaging10 VIAL in 1 CARTON (70594-081-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-081-01)
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 71288000520

NDC 971288-005
NDC 1071288-005-20
NDC Item71288000520
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-005-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-005-21)
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288000521

NDC 971288-005
NDC 1071288-005-21
NDC Item71288000521
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288003120

NDC 971288-031
NDC 1071288-031-20
NDC Item71288003120
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003121

NDC 971288-031
NDC 1071288-031-21
NDC Item71288003121
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-21) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-20)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003191

NDC 971288-031
NDC 1071288-031-91
NDC Item71288003191
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003192

NDC 971288-031
NDC 1071288-031-92
NDC Item71288003192
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-92) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-91)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 72485041601

NDC 972485-416
NDC 1072485-416-01
NDC Item72485041601
Packaging1 in 1 VIAL
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72485041610

NDC 972485-416
NDC 1072485-416-10
NDC Item72485041610
Packaging10 VIAL in 1 CARTON (72485-416-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72485-416-01)
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72572002101

NDC 972572-021
NDC 1072572-021-01
NDC Item72572002101
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72572002110

NDC 972572-021
NDC 1072572-021-10
NDC Item72572002110
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72572-021-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72572-021-01)
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72603022001

NDC 972603-220
NDC 1072603-220-01
NDC Item72603022001
Packaging1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusactive
Related queriesProperties for NDC 9 72603-220

NDC Item 72603022010

NDC 972603-220
NDC 1072603-220-10
NDC Item72603022010
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72603-220-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 72603-220

NDC Item 82449051301

NDC 982449-513
NDC 1082449-513-01
NDC Item82449051301
Packaging1 VIAL in 1 CARTON (82449-513-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 82449051302

NDC 982449-513
NDC 1082449-513-02
NDC Item82449051302
Packaging10 VIAL in 1 CARTON (82449-513-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 00409268901

NDC 90409-2689
NDC 100409-2689-01
NDC Item00409268901
Packaging10 VIAL in 1 TRAY (0409-2689-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0409-2689-21)
ANDAANDA065310
FDA SPL set id806154
LabelerHospira, Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-07-25
Marketing statusACTIVE
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268921

NDC 90409-2689
NDC 100409-2689-21
NDC Item00409268921
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268949

NDC 90409-2689
NDC 100409-2689-49
NDC Item00409268949
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00641611601

NDC 90641-6116
NDC 100641-6116-01
NDC Item00641611601
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611610

NDC 90641-6116
NDC 100641-6116-10
NDC Item00641611610
Packaging10 VIAL in 1 CARTON (0641-6116-10) / 1.5 g in 1 VIAL (0641-6116-01)
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611901

NDC 90641-6119
NDC 100641-6119-01
NDC Item00641611901
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641611910

NDC 90641-6119
NDC 100641-6119-10
NDC Item00641611910
Packaging10 VIAL in 1 CARTON (0641-6119-10) / 1.5 g in 1 VIAL (0641-6119-01)
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641612201

NDC 90641-6122
NDC 100641-6122-01
NDC Item00641612201
Packaging4 mL in 1 VIAL
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00641612210

NDC 90641-6122
NDC 100641-6122-10
NDC Item00641612210
Packaging10 VIAL in 1 CARTON (0641-6122-10) / 4 mL in 1 VIAL (0641-6122-01)
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00781303270

NDC 90781-3032
NDC 100781-3032-70
NDC Item00781303270
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 00781303295

NDC 90781-3032
NDC 100781-3032-95
NDC Item00781303295
Packaging10 VIAL in 1 CARTON (0781-3032-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-3032-70)
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 25021014220

NDC 925021-142
NDC 1025021-142-20
NDC Item25021014220
Packaging10 VIAL in 1 CARTON (25021-142-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065406
FDA SPL set id612973
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-06-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 25021-142

NDC Item 25021018620

NDC 925021-186
NDC 1025021-186-20
NDC Item25021018620
Packaging10 VIAL in 1 CARTON (25021-186-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090579
FDA SPL set id549185
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-03-31
Marketing effective time low2017-08-15
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 25021-186

NDC Item 44567021010

NDC 944567-210
NDC 1044567-210-10
NDC Item44567021010
Packaging10 VIAL in 1 CARTON (44567-210-10) / 10 mL in 1 VIAL
ANDAANDA065176
FDA SPL set id803837
LabelerWG Critical Care, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 44567-210

NDC Item 55150011601

NDC 955150-116
NDC 1055150-116-01
NDC Item55150011601
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011610

NDC 955150-116
NDC 1055150-116-10
NDC Item55150011610
Packaging10 VIAL in 1 CARTON (55150-116-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011620

NDC 955150-116
NDC 1055150-116-20
NDC Item55150011620
Packaging10 VIAL in 1 CARTON (55150-116-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150017899

NDC 955150-178
NDC 1055150-178-99
NDC Item55150017899
Packaging10 BOTTLE in 1 BOX (55150-178-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE
ANDAANDA090340
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-09-13
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-178

NDC Item 63323036820

NDC 963323-368
NDC 1063323-368-20
NDC Item63323036820
Packaging10 VIAL in 1 CARTON (63323-368-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065222
FDA SPL set id460623
LabelerFresenius Kabi USA, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2016-05-05
Marketing effective time low2005-11-29
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 63323-368

NDC Item 66794020602

NDC 966794-206
NDC 1066794-206-02
NDC Item66794020602
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794020641

NDC 966794-206
NDC 1066794-206-41
NDC Item66794020641
Packaging10 VIAL in 1 CARTON (66794-206-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-206-02)
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794024102

NDC 966794-241
NDC 1066794-241-02
NDC Item66794024102
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 66794024141

NDC 966794-241
NDC 1066794-241-41
NDC Item66794024141
Packaging10 VIAL in 1 CARTON (66794-241-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-241-02)
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 67457034810

NDC 967457-348
NDC 1067457-348-10
NDC Item67457034810
Packaging10 VIAL in 1 CARTON (67457-348-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67457034815

NDC 967457-348
NDC 1067457-348-15
NDC Item67457034815
Packaging1 VIAL in 1 CARTON (67457-348-15) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67850013000

NDC 967850-130
NDC 1067850-130-00
NDC Item67850013000
Packaging1 in 1 VIAL, GLASS
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 67850013010

NDC 967850-130
NDC 1067850-130-10
NDC Item67850013010
Packaging10 VIAL, GLASS in 1 CARTON (67850-130-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (67850-130-00)
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 70594008101

NDC 970594-081
NDC 1070594-081-01
NDC Item70594008101
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 70594008102

NDC 970594-081
NDC 1070594-081-02
NDC Item70594008102
Packaging10 VIAL in 1 CARTON (70594-081-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-081-01)
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 71288000520

NDC 971288-005
NDC 1071288-005-20
NDC Item71288000520
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-005-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-005-21)
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288000521

NDC 971288-005
NDC 1071288-005-21
NDC Item71288000521
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288003120

NDC 971288-031
NDC 1071288-031-20
NDC Item71288003120
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003121

NDC 971288-031
NDC 1071288-031-21
NDC Item71288003121
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-21) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-20)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003191

NDC 971288-031
NDC 1071288-031-91
NDC Item71288003191
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003192

NDC 971288-031
NDC 1071288-031-92
NDC Item71288003192
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-92) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-91)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 72485041601

NDC 972485-416
NDC 1072485-416-01
NDC Item72485041601
Packaging1 in 1 VIAL
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72485041610

NDC 972485-416
NDC 1072485-416-10
NDC Item72485041610
Packaging10 VIAL in 1 CARTON (72485-416-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72485-416-01)
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72572002101

NDC 972572-021
NDC 1072572-021-01
NDC Item72572002101
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72572002110

NDC 972572-021
NDC 1072572-021-10
NDC Item72572002110
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72572-021-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72572-021-01)
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72603022001

NDC 972603-220
NDC 1072603-220-01
NDC Item72603022001
Packaging1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusactive
Related queriesProperties for NDC 9 72603-220

NDC Item 72603022010

NDC 972603-220
NDC 1072603-220-10
NDC Item72603022010
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72603-220-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 72603-220

NDC Item 82449051301

NDC 982449-513
NDC 1082449-513-01
NDC Item82449051301
Packaging1 VIAL in 1 CARTON (82449-513-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 82449051302

NDC 982449-513
NDC 1082449-513-02
NDC Item82449051302
Packaging10 VIAL in 1 CARTON (82449-513-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 00409268901

NDC 90409-2689
NDC 100409-2689-01
NDC Item00409268901
Packaging10 VIAL in 1 TRAY (0409-2689-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0409-2689-21)
ANDAANDA065310
FDA SPL set id806154
LabelerHospira, Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-07-25
Marketing statusACTIVE
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268921

NDC 90409-2689
NDC 100409-2689-21
NDC Item00409268921
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268949

NDC 90409-2689
NDC 100409-2689-49
NDC Item00409268949
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00641611601

NDC 90641-6116
NDC 100641-6116-01
NDC Item00641611601
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611610

NDC 90641-6116
NDC 100641-6116-10
NDC Item00641611610
Packaging10 VIAL in 1 CARTON (0641-6116-10) / 1.5 g in 1 VIAL (0641-6116-01)
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611901

NDC 90641-6119
NDC 100641-6119-01
NDC Item00641611901
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641611910

NDC 90641-6119
NDC 100641-6119-10
NDC Item00641611910
Packaging10 VIAL in 1 CARTON (0641-6119-10) / 1.5 g in 1 VIAL (0641-6119-01)
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641612201

NDC 90641-6122
NDC 100641-6122-01
NDC Item00641612201
Packaging4 mL in 1 VIAL
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00641612210

NDC 90641-6122
NDC 100641-6122-10
NDC Item00641612210
Packaging10 VIAL in 1 CARTON (0641-6122-10) / 4 mL in 1 VIAL (0641-6122-01)
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00781303270

NDC 90781-3032
NDC 100781-3032-70
NDC Item00781303270
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 00781303295

NDC 90781-3032
NDC 100781-3032-95
NDC Item00781303295
Packaging10 VIAL in 1 CARTON (0781-3032-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-3032-70)
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 25021014220

NDC 925021-142
NDC 1025021-142-20
NDC Item25021014220
Packaging10 VIAL in 1 CARTON (25021-142-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065406
FDA SPL set id612973
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-06-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 25021-142

NDC Item 25021018620

NDC 925021-186
NDC 1025021-186-20
NDC Item25021018620
Packaging10 VIAL in 1 CARTON (25021-186-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090579
FDA SPL set id549185
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-03-31
Marketing effective time low2017-08-15
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 25021-186

NDC Item 44567021010

NDC 944567-210
NDC 1044567-210-10
NDC Item44567021010
Packaging10 VIAL in 1 CARTON (44567-210-10) / 10 mL in 1 VIAL
ANDAANDA065176
FDA SPL set id803837
LabelerWG Critical Care, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 44567-210

NDC Item 55150011601

NDC 955150-116
NDC 1055150-116-01
NDC Item55150011601
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011610

NDC 955150-116
NDC 1055150-116-10
NDC Item55150011610
Packaging10 VIAL in 1 CARTON (55150-116-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011620

NDC 955150-116
NDC 1055150-116-20
NDC Item55150011620
Packaging10 VIAL in 1 CARTON (55150-116-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150017899

NDC 955150-178
NDC 1055150-178-99
NDC Item55150017899
Packaging10 BOTTLE in 1 BOX (55150-178-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE
ANDAANDA090340
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-09-13
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-178

NDC Item 63323036820

NDC 963323-368
NDC 1063323-368-20
NDC Item63323036820
Packaging10 VIAL in 1 CARTON (63323-368-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065222
FDA SPL set id460623
LabelerFresenius Kabi USA, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2016-05-05
Marketing effective time low2005-11-29
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 63323-368

NDC Item 66794020602

NDC 966794-206
NDC 1066794-206-02
NDC Item66794020602
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794020641

NDC 966794-206
NDC 1066794-206-41
NDC Item66794020641
Packaging10 VIAL in 1 CARTON (66794-206-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-206-02)
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794024102

NDC 966794-241
NDC 1066794-241-02
NDC Item66794024102
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 66794024141

NDC 966794-241
NDC 1066794-241-41
NDC Item66794024141
Packaging10 VIAL in 1 CARTON (66794-241-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-241-02)
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 67457034810

NDC 967457-348
NDC 1067457-348-10
NDC Item67457034810
Packaging10 VIAL in 1 CARTON (67457-348-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67457034815

NDC 967457-348
NDC 1067457-348-15
NDC Item67457034815
Packaging1 VIAL in 1 CARTON (67457-348-15) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67850013000

NDC 967850-130
NDC 1067850-130-00
NDC Item67850013000
Packaging1 in 1 VIAL, GLASS
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 67850013010

NDC 967850-130
NDC 1067850-130-10
NDC Item67850013010
Packaging10 VIAL, GLASS in 1 CARTON (67850-130-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (67850-130-00)
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 70594008101

NDC 970594-081
NDC 1070594-081-01
NDC Item70594008101
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 70594008102

NDC 970594-081
NDC 1070594-081-02
NDC Item70594008102
Packaging10 VIAL in 1 CARTON (70594-081-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-081-01)
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 71288000520

NDC 971288-005
NDC 1071288-005-20
NDC Item71288000520
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-005-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-005-21)
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288000521

NDC 971288-005
NDC 1071288-005-21
NDC Item71288000521
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288003120

NDC 971288-031
NDC 1071288-031-20
NDC Item71288003120
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003121

NDC 971288-031
NDC 1071288-031-21
NDC Item71288003121
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-21) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-20)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003191

NDC 971288-031
NDC 1071288-031-91
NDC Item71288003191
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003192

NDC 971288-031
NDC 1071288-031-92
NDC Item71288003192
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-92) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-91)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 72485041601

NDC 972485-416
NDC 1072485-416-01
NDC Item72485041601
Packaging1 in 1 VIAL
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72485041610

NDC 972485-416
NDC 1072485-416-10
NDC Item72485041610
Packaging10 VIAL in 1 CARTON (72485-416-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72485-416-01)
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72572002101

NDC 972572-021
NDC 1072572-021-01
NDC Item72572002101
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72572002110

NDC 972572-021
NDC 1072572-021-10
NDC Item72572002110
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72572-021-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72572-021-01)
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72603022001

NDC 972603-220
NDC 1072603-220-01
NDC Item72603022001
Packaging1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusactive
Related queriesProperties for NDC 9 72603-220

NDC Item 72603022010

NDC 972603-220
NDC 1072603-220-10
NDC Item72603022010
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72603-220-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 72603-220

NDC Item 82449051301

NDC 982449-513
NDC 1082449-513-01
NDC Item82449051301
Packaging1 VIAL in 1 CARTON (82449-513-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 82449051302

NDC 982449-513
NDC 1082449-513-02
NDC Item82449051302
Packaging10 VIAL in 1 CARTON (82449-513-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 00409268901

NDC 90409-2689
NDC 100409-2689-01
NDC Item00409268901
Packaging10 VIAL in 1 TRAY (0409-2689-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0409-2689-21)
ANDAANDA065310
FDA SPL set id806154
LabelerHospira, Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-07-25
Marketing statusACTIVE
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268921

NDC 90409-2689
NDC 100409-2689-21
NDC Item00409268921
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268949

NDC 90409-2689
NDC 100409-2689-49
NDC Item00409268949
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00641611601

NDC 90641-6116
NDC 100641-6116-01
NDC Item00641611601
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611610

NDC 90641-6116
NDC 100641-6116-10
NDC Item00641611610
Packaging10 VIAL in 1 CARTON (0641-6116-10) / 1.5 g in 1 VIAL (0641-6116-01)
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611901

NDC 90641-6119
NDC 100641-6119-01
NDC Item00641611901
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641611910

NDC 90641-6119
NDC 100641-6119-10
NDC Item00641611910
Packaging10 VIAL in 1 CARTON (0641-6119-10) / 1.5 g in 1 VIAL (0641-6119-01)
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641612201

NDC 90641-6122
NDC 100641-6122-01
NDC Item00641612201
Packaging4 mL in 1 VIAL
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00641612210

NDC 90641-6122
NDC 100641-6122-10
NDC Item00641612210
Packaging10 VIAL in 1 CARTON (0641-6122-10) / 4 mL in 1 VIAL (0641-6122-01)
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00781303270

NDC 90781-3032
NDC 100781-3032-70
NDC Item00781303270
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 00781303295

NDC 90781-3032
NDC 100781-3032-95
NDC Item00781303295
Packaging10 VIAL in 1 CARTON (0781-3032-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-3032-70)
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 25021014220

NDC 925021-142
NDC 1025021-142-20
NDC Item25021014220
Packaging10 VIAL in 1 CARTON (25021-142-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065406
FDA SPL set id612973
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-06-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 25021-142

NDC Item 25021018620

NDC 925021-186
NDC 1025021-186-20
NDC Item25021018620
Packaging10 VIAL in 1 CARTON (25021-186-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090579
FDA SPL set id549185
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-03-31
Marketing effective time low2017-08-15
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 25021-186

NDC Item 44567021010

NDC 944567-210
NDC 1044567-210-10
NDC Item44567021010
Packaging10 VIAL in 1 CARTON (44567-210-10) / 10 mL in 1 VIAL
ANDAANDA065176
FDA SPL set id803837
LabelerWG Critical Care, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 44567-210

NDC Item 55150011601

NDC 955150-116
NDC 1055150-116-01
NDC Item55150011601
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011610

NDC 955150-116
NDC 1055150-116-10
NDC Item55150011610
Packaging10 VIAL in 1 CARTON (55150-116-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011620

NDC 955150-116
NDC 1055150-116-20
NDC Item55150011620
Packaging10 VIAL in 1 CARTON (55150-116-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150017899

NDC 955150-178
NDC 1055150-178-99
NDC Item55150017899
Packaging10 BOTTLE in 1 BOX (55150-178-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE
ANDAANDA090340
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-09-13
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-178

NDC Item 63323036820

NDC 963323-368
NDC 1063323-368-20
NDC Item63323036820
Packaging10 VIAL in 1 CARTON (63323-368-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065222
FDA SPL set id460623
LabelerFresenius Kabi USA, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2016-05-05
Marketing effective time low2005-11-29
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 63323-368

NDC Item 66794020602

NDC 966794-206
NDC 1066794-206-02
NDC Item66794020602
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794020641

NDC 966794-206
NDC 1066794-206-41
NDC Item66794020641
Packaging10 VIAL in 1 CARTON (66794-206-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-206-02)
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794024102

NDC 966794-241
NDC 1066794-241-02
NDC Item66794024102
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 66794024141

NDC 966794-241
NDC 1066794-241-41
NDC Item66794024141
Packaging10 VIAL in 1 CARTON (66794-241-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-241-02)
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 67457034810

NDC 967457-348
NDC 1067457-348-10
NDC Item67457034810
Packaging10 VIAL in 1 CARTON (67457-348-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67457034815

NDC 967457-348
NDC 1067457-348-15
NDC Item67457034815
Packaging1 VIAL in 1 CARTON (67457-348-15) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67850013000

NDC 967850-130
NDC 1067850-130-00
NDC Item67850013000
Packaging1 in 1 VIAL, GLASS
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 67850013010

NDC 967850-130
NDC 1067850-130-10
NDC Item67850013010
Packaging10 VIAL, GLASS in 1 CARTON (67850-130-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (67850-130-00)
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 70594008101

NDC 970594-081
NDC 1070594-081-01
NDC Item70594008101
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 70594008102

NDC 970594-081
NDC 1070594-081-02
NDC Item70594008102
Packaging10 VIAL in 1 CARTON (70594-081-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-081-01)
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 71288000520

NDC 971288-005
NDC 1071288-005-20
NDC Item71288000520
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-005-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-005-21)
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288000521

NDC 971288-005
NDC 1071288-005-21
NDC Item71288000521
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288003120

NDC 971288-031
NDC 1071288-031-20
NDC Item71288003120
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003121

NDC 971288-031
NDC 1071288-031-21
NDC Item71288003121
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-21) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-20)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003191

NDC 971288-031
NDC 1071288-031-91
NDC Item71288003191
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003192

NDC 971288-031
NDC 1071288-031-92
NDC Item71288003192
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-92) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-91)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 72485041601

NDC 972485-416
NDC 1072485-416-01
NDC Item72485041601
Packaging1 in 1 VIAL
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72485041610

NDC 972485-416
NDC 1072485-416-10
NDC Item72485041610
Packaging10 VIAL in 1 CARTON (72485-416-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72485-416-01)
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72572002101

NDC 972572-021
NDC 1072572-021-01
NDC Item72572002101
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72572002110

NDC 972572-021
NDC 1072572-021-10
NDC Item72572002110
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72572-021-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72572-021-01)
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72603022001

NDC 972603-220
NDC 1072603-220-01
NDC Item72603022001
Packaging1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusactive
Related queriesProperties for NDC 9 72603-220

NDC Item 72603022010

NDC 972603-220
NDC 1072603-220-10
NDC Item72603022010
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72603-220-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 72603-220

NDC Item 82449051301

NDC 982449-513
NDC 1082449-513-01
NDC Item82449051301
Packaging1 VIAL in 1 CARTON (82449-513-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 82449051302

NDC 982449-513
NDC 1082449-513-02
NDC Item82449051302
Packaging10 VIAL in 1 CARTON (82449-513-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 00409268901

NDC 90409-2689
NDC 100409-2689-01
NDC Item00409268901
Packaging10 VIAL in 1 TRAY (0409-2689-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0409-2689-21)
ANDAANDA065310
FDA SPL set id806154
LabelerHospira, Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-07-25
Marketing statusACTIVE
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268921

NDC 90409-2689
NDC 100409-2689-21
NDC Item00409268921
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268949

NDC 90409-2689
NDC 100409-2689-49
NDC Item00409268949
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00641611601

NDC 90641-6116
NDC 100641-6116-01
NDC Item00641611601
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611610

NDC 90641-6116
NDC 100641-6116-10
NDC Item00641611610
Packaging10 VIAL in 1 CARTON (0641-6116-10) / 1.5 g in 1 VIAL (0641-6116-01)
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611901

NDC 90641-6119
NDC 100641-6119-01
NDC Item00641611901
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641611910

NDC 90641-6119
NDC 100641-6119-10
NDC Item00641611910
Packaging10 VIAL in 1 CARTON (0641-6119-10) / 1.5 g in 1 VIAL (0641-6119-01)
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641612201

NDC 90641-6122
NDC 100641-6122-01
NDC Item00641612201
Packaging4 mL in 1 VIAL
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00641612210

NDC 90641-6122
NDC 100641-6122-10
NDC Item00641612210
Packaging10 VIAL in 1 CARTON (0641-6122-10) / 4 mL in 1 VIAL (0641-6122-01)
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00781303270

NDC 90781-3032
NDC 100781-3032-70
NDC Item00781303270
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 00781303295

NDC 90781-3032
NDC 100781-3032-95
NDC Item00781303295
Packaging10 VIAL in 1 CARTON (0781-3032-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-3032-70)
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 25021014220

NDC 925021-142
NDC 1025021-142-20
NDC Item25021014220
Packaging10 VIAL in 1 CARTON (25021-142-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065406
FDA SPL set id612973
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-06-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 25021-142

NDC Item 25021018620

NDC 925021-186
NDC 1025021-186-20
NDC Item25021018620
Packaging10 VIAL in 1 CARTON (25021-186-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090579
FDA SPL set id549185
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-03-31
Marketing effective time low2017-08-15
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 25021-186

NDC Item 44567021010

NDC 944567-210
NDC 1044567-210-10
NDC Item44567021010
Packaging10 VIAL in 1 CARTON (44567-210-10) / 10 mL in 1 VIAL
ANDAANDA065176
FDA SPL set id803837
LabelerWG Critical Care, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 44567-210

NDC Item 55150011601

NDC 955150-116
NDC 1055150-116-01
NDC Item55150011601
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011610

NDC 955150-116
NDC 1055150-116-10
NDC Item55150011610
Packaging10 VIAL in 1 CARTON (55150-116-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011620

NDC 955150-116
NDC 1055150-116-20
NDC Item55150011620
Packaging10 VIAL in 1 CARTON (55150-116-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150017899

NDC 955150-178
NDC 1055150-178-99
NDC Item55150017899
Packaging10 BOTTLE in 1 BOX (55150-178-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE
ANDAANDA090340
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-09-13
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-178

NDC Item 63323036820

NDC 963323-368
NDC 1063323-368-20
NDC Item63323036820
Packaging10 VIAL in 1 CARTON (63323-368-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065222
FDA SPL set id460623
LabelerFresenius Kabi USA, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2016-05-05
Marketing effective time low2005-11-29
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 63323-368

NDC Item 66794020602

NDC 966794-206
NDC 1066794-206-02
NDC Item66794020602
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794020641

NDC 966794-206
NDC 1066794-206-41
NDC Item66794020641
Packaging10 VIAL in 1 CARTON (66794-206-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-206-02)
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794024102

NDC 966794-241
NDC 1066794-241-02
NDC Item66794024102
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 66794024141

NDC 966794-241
NDC 1066794-241-41
NDC Item66794024141
Packaging10 VIAL in 1 CARTON (66794-241-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-241-02)
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 67457034810

NDC 967457-348
NDC 1067457-348-10
NDC Item67457034810
Packaging10 VIAL in 1 CARTON (67457-348-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67457034815

NDC 967457-348
NDC 1067457-348-15
NDC Item67457034815
Packaging1 VIAL in 1 CARTON (67457-348-15) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67850013000

NDC 967850-130
NDC 1067850-130-00
NDC Item67850013000
Packaging1 in 1 VIAL, GLASS
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 67850013010

NDC 967850-130
NDC 1067850-130-10
NDC Item67850013010
Packaging10 VIAL, GLASS in 1 CARTON (67850-130-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (67850-130-00)
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 70594008101

NDC 970594-081
NDC 1070594-081-01
NDC Item70594008101
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 70594008102

NDC 970594-081
NDC 1070594-081-02
NDC Item70594008102
Packaging10 VIAL in 1 CARTON (70594-081-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-081-01)
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 71288000520

NDC 971288-005
NDC 1071288-005-20
NDC Item71288000520
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-005-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-005-21)
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288000521

NDC 971288-005
NDC 1071288-005-21
NDC Item71288000521
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288003120

NDC 971288-031
NDC 1071288-031-20
NDC Item71288003120
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003121

NDC 971288-031
NDC 1071288-031-21
NDC Item71288003121
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-21) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-20)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003191

NDC 971288-031
NDC 1071288-031-91
NDC Item71288003191
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003192

NDC 971288-031
NDC 1071288-031-92
NDC Item71288003192
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-92) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-91)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 72485041601

NDC 972485-416
NDC 1072485-416-01
NDC Item72485041601
Packaging1 in 1 VIAL
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72485041610

NDC 972485-416
NDC 1072485-416-10
NDC Item72485041610
Packaging10 VIAL in 1 CARTON (72485-416-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72485-416-01)
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72572002101

NDC 972572-021
NDC 1072572-021-01
NDC Item72572002101
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72572002110

NDC 972572-021
NDC 1072572-021-10
NDC Item72572002110
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72572-021-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72572-021-01)
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72603022001

NDC 972603-220
NDC 1072603-220-01
NDC Item72603022001
Packaging1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusactive
Related queriesProperties for NDC 9 72603-220

NDC Item 72603022010

NDC 972603-220
NDC 1072603-220-10
NDC Item72603022010
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72603-220-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 72603-220

NDC Item 82449051301

NDC 982449-513
NDC 1082449-513-01
NDC Item82449051301
Packaging1 VIAL in 1 CARTON (82449-513-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 82449051302

NDC 982449-513
NDC 1082449-513-02
NDC Item82449051302
Packaging10 VIAL in 1 CARTON (82449-513-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 00409268901

NDC 90409-2689
NDC 100409-2689-01
NDC Item00409268901
Packaging10 VIAL in 1 TRAY (0409-2689-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0409-2689-21)
ANDAANDA065310
FDA SPL set id806154
LabelerHospira, Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-07-25
Marketing statusACTIVE
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268921

NDC 90409-2689
NDC 100409-2689-21
NDC Item00409268921
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268949

NDC 90409-2689
NDC 100409-2689-49
NDC Item00409268949
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00641611601

NDC 90641-6116
NDC 100641-6116-01
NDC Item00641611601
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611610

NDC 90641-6116
NDC 100641-6116-10
NDC Item00641611610
Packaging10 VIAL in 1 CARTON (0641-6116-10) / 1.5 g in 1 VIAL (0641-6116-01)
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611901

NDC 90641-6119
NDC 100641-6119-01
NDC Item00641611901
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641611910

NDC 90641-6119
NDC 100641-6119-10
NDC Item00641611910
Packaging10 VIAL in 1 CARTON (0641-6119-10) / 1.5 g in 1 VIAL (0641-6119-01)
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641612201

NDC 90641-6122
NDC 100641-6122-01
NDC Item00641612201
Packaging4 mL in 1 VIAL
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00641612210

NDC 90641-6122
NDC 100641-6122-10
NDC Item00641612210
Packaging10 VIAL in 1 CARTON (0641-6122-10) / 4 mL in 1 VIAL (0641-6122-01)
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00781303270

NDC 90781-3032
NDC 100781-3032-70
NDC Item00781303270
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 00781303295

NDC 90781-3032
NDC 100781-3032-95
NDC Item00781303295
Packaging10 VIAL in 1 CARTON (0781-3032-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-3032-70)
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 25021014220

NDC 925021-142
NDC 1025021-142-20
NDC Item25021014220
Packaging10 VIAL in 1 CARTON (25021-142-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065406
FDA SPL set id612973
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-06-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 25021-142

NDC Item 25021018620

NDC 925021-186
NDC 1025021-186-20
NDC Item25021018620
Packaging10 VIAL in 1 CARTON (25021-186-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090579
FDA SPL set id549185
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-03-31
Marketing effective time low2017-08-15
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 25021-186

NDC Item 44567021010

NDC 944567-210
NDC 1044567-210-10
NDC Item44567021010
Packaging10 VIAL in 1 CARTON (44567-210-10) / 10 mL in 1 VIAL
ANDAANDA065176
FDA SPL set id803837
LabelerWG Critical Care, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 44567-210

NDC Item 55150011601

NDC 955150-116
NDC 1055150-116-01
NDC Item55150011601
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011610

NDC 955150-116
NDC 1055150-116-10
NDC Item55150011610
Packaging10 VIAL in 1 CARTON (55150-116-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011620

NDC 955150-116
NDC 1055150-116-20
NDC Item55150011620
Packaging10 VIAL in 1 CARTON (55150-116-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150017899

NDC 955150-178
NDC 1055150-178-99
NDC Item55150017899
Packaging10 BOTTLE in 1 BOX (55150-178-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE
ANDAANDA090340
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-09-13
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-178

NDC Item 63323036820

NDC 963323-368
NDC 1063323-368-20
NDC Item63323036820
Packaging10 VIAL in 1 CARTON (63323-368-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065222
FDA SPL set id460623
LabelerFresenius Kabi USA, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2016-05-05
Marketing effective time low2005-11-29
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 63323-368

NDC Item 66794020602

NDC 966794-206
NDC 1066794-206-02
NDC Item66794020602
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794020641

NDC 966794-206
NDC 1066794-206-41
NDC Item66794020641
Packaging10 VIAL in 1 CARTON (66794-206-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-206-02)
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794024102

NDC 966794-241
NDC 1066794-241-02
NDC Item66794024102
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 66794024141

NDC 966794-241
NDC 1066794-241-41
NDC Item66794024141
Packaging10 VIAL in 1 CARTON (66794-241-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-241-02)
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 67457034810

NDC 967457-348
NDC 1067457-348-10
NDC Item67457034810
Packaging10 VIAL in 1 CARTON (67457-348-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67457034815

NDC 967457-348
NDC 1067457-348-15
NDC Item67457034815
Packaging1 VIAL in 1 CARTON (67457-348-15) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67850013000

NDC 967850-130
NDC 1067850-130-00
NDC Item67850013000
Packaging1 in 1 VIAL, GLASS
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 67850013010

NDC 967850-130
NDC 1067850-130-10
NDC Item67850013010
Packaging10 VIAL, GLASS in 1 CARTON (67850-130-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (67850-130-00)
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 70594008101

NDC 970594-081
NDC 1070594-081-01
NDC Item70594008101
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 70594008102

NDC 970594-081
NDC 1070594-081-02
NDC Item70594008102
Packaging10 VIAL in 1 CARTON (70594-081-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-081-01)
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 71288000520

NDC 971288-005
NDC 1071288-005-20
NDC Item71288000520
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-005-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-005-21)
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288000521

NDC 971288-005
NDC 1071288-005-21
NDC Item71288000521
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288003120

NDC 971288-031
NDC 1071288-031-20
NDC Item71288003120
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003121

NDC 971288-031
NDC 1071288-031-21
NDC Item71288003121
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-21) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-20)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003191

NDC 971288-031
NDC 1071288-031-91
NDC Item71288003191
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003192

NDC 971288-031
NDC 1071288-031-92
NDC Item71288003192
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-92) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-91)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 72485041601

NDC 972485-416
NDC 1072485-416-01
NDC Item72485041601
Packaging1 in 1 VIAL
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72485041610

NDC 972485-416
NDC 1072485-416-10
NDC Item72485041610
Packaging10 VIAL in 1 CARTON (72485-416-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72485-416-01)
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72572002101

NDC 972572-021
NDC 1072572-021-01
NDC Item72572002101
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72572002110

NDC 972572-021
NDC 1072572-021-10
NDC Item72572002110
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72572-021-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72572-021-01)
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72603022001

NDC 972603-220
NDC 1072603-220-01
NDC Item72603022001
Packaging1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusactive
Related queriesProperties for NDC 9 72603-220

NDC Item 72603022010

NDC 972603-220
NDC 1072603-220-10
NDC Item72603022010
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72603-220-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 72603-220

NDC Item 82449051301

NDC 982449-513
NDC 1082449-513-01
NDC Item82449051301
Packaging1 VIAL in 1 CARTON (82449-513-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 82449051302

NDC 982449-513
NDC 1082449-513-02
NDC Item82449051302
Packaging10 VIAL in 1 CARTON (82449-513-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 00409268901

NDC 90409-2689
NDC 100409-2689-01
NDC Item00409268901
Packaging10 VIAL in 1 TRAY (0409-2689-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0409-2689-21)
ANDAANDA065310
FDA SPL set id806154
LabelerHospira, Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-07-25
Marketing statusACTIVE
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268921

NDC 90409-2689
NDC 100409-2689-21
NDC Item00409268921
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268949

NDC 90409-2689
NDC 100409-2689-49
NDC Item00409268949
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00641611601

NDC 90641-6116
NDC 100641-6116-01
NDC Item00641611601
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611610

NDC 90641-6116
NDC 100641-6116-10
NDC Item00641611610
Packaging10 VIAL in 1 CARTON (0641-6116-10) / 1.5 g in 1 VIAL (0641-6116-01)
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611901

NDC 90641-6119
NDC 100641-6119-01
NDC Item00641611901
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641611910

NDC 90641-6119
NDC 100641-6119-10
NDC Item00641611910
Packaging10 VIAL in 1 CARTON (0641-6119-10) / 1.5 g in 1 VIAL (0641-6119-01)
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641612201

NDC 90641-6122
NDC 100641-6122-01
NDC Item00641612201
Packaging4 mL in 1 VIAL
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00641612210

NDC 90641-6122
NDC 100641-6122-10
NDC Item00641612210
Packaging10 VIAL in 1 CARTON (0641-6122-10) / 4 mL in 1 VIAL (0641-6122-01)
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00781303270

NDC 90781-3032
NDC 100781-3032-70
NDC Item00781303270
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 00781303295

NDC 90781-3032
NDC 100781-3032-95
NDC Item00781303295
Packaging10 VIAL in 1 CARTON (0781-3032-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-3032-70)
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 25021014220

NDC 925021-142
NDC 1025021-142-20
NDC Item25021014220
Packaging10 VIAL in 1 CARTON (25021-142-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065406
FDA SPL set id612973
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-06-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 25021-142

NDC Item 25021018620

NDC 925021-186
NDC 1025021-186-20
NDC Item25021018620
Packaging10 VIAL in 1 CARTON (25021-186-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090579
FDA SPL set id549185
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-03-31
Marketing effective time low2017-08-15
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 25021-186

NDC Item 44567021010

NDC 944567-210
NDC 1044567-210-10
NDC Item44567021010
Packaging10 VIAL in 1 CARTON (44567-210-10) / 10 mL in 1 VIAL
ANDAANDA065176
FDA SPL set id803837
LabelerWG Critical Care, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 44567-210

NDC Item 55150011601

NDC 955150-116
NDC 1055150-116-01
NDC Item55150011601
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011610

NDC 955150-116
NDC 1055150-116-10
NDC Item55150011610
Packaging10 VIAL in 1 CARTON (55150-116-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011620

NDC 955150-116
NDC 1055150-116-20
NDC Item55150011620
Packaging10 VIAL in 1 CARTON (55150-116-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150017899

NDC 955150-178
NDC 1055150-178-99
NDC Item55150017899
Packaging10 BOTTLE in 1 BOX (55150-178-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE
ANDAANDA090340
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-09-13
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-178

NDC Item 63323036820

NDC 963323-368
NDC 1063323-368-20
NDC Item63323036820
Packaging10 VIAL in 1 CARTON (63323-368-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065222
FDA SPL set id460623
LabelerFresenius Kabi USA, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2016-05-05
Marketing effective time low2005-11-29
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 63323-368

NDC Item 66794020602

NDC 966794-206
NDC 1066794-206-02
NDC Item66794020602
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794020641

NDC 966794-206
NDC 1066794-206-41
NDC Item66794020641
Packaging10 VIAL in 1 CARTON (66794-206-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-206-02)
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794024102

NDC 966794-241
NDC 1066794-241-02
NDC Item66794024102
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 66794024141

NDC 966794-241
NDC 1066794-241-41
NDC Item66794024141
Packaging10 VIAL in 1 CARTON (66794-241-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-241-02)
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 67457034810

NDC 967457-348
NDC 1067457-348-10
NDC Item67457034810
Packaging10 VIAL in 1 CARTON (67457-348-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67457034815

NDC 967457-348
NDC 1067457-348-15
NDC Item67457034815
Packaging1 VIAL in 1 CARTON (67457-348-15) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67850013000

NDC 967850-130
NDC 1067850-130-00
NDC Item67850013000
Packaging1 in 1 VIAL, GLASS
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 67850013010

NDC 967850-130
NDC 1067850-130-10
NDC Item67850013010
Packaging10 VIAL, GLASS in 1 CARTON (67850-130-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (67850-130-00)
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 70594008101

NDC 970594-081
NDC 1070594-081-01
NDC Item70594008101
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 70594008102

NDC 970594-081
NDC 1070594-081-02
NDC Item70594008102
Packaging10 VIAL in 1 CARTON (70594-081-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-081-01)
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 71288000520

NDC 971288-005
NDC 1071288-005-20
NDC Item71288000520
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-005-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-005-21)
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288000521

NDC 971288-005
NDC 1071288-005-21
NDC Item71288000521
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288003120

NDC 971288-031
NDC 1071288-031-20
NDC Item71288003120
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003121

NDC 971288-031
NDC 1071288-031-21
NDC Item71288003121
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-21) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-20)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003191

NDC 971288-031
NDC 1071288-031-91
NDC Item71288003191
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003192

NDC 971288-031
NDC 1071288-031-92
NDC Item71288003192
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-92) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-91)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 72485041601

NDC 972485-416
NDC 1072485-416-01
NDC Item72485041601
Packaging1 in 1 VIAL
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72485041610

NDC 972485-416
NDC 1072485-416-10
NDC Item72485041610
Packaging10 VIAL in 1 CARTON (72485-416-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72485-416-01)
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72572002101

NDC 972572-021
NDC 1072572-021-01
NDC Item72572002101
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72572002110

NDC 972572-021
NDC 1072572-021-10
NDC Item72572002110
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72572-021-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72572-021-01)
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72603022001

NDC 972603-220
NDC 1072603-220-01
NDC Item72603022001
Packaging1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusactive
Related queriesProperties for NDC 9 72603-220

NDC Item 72603022010

NDC 972603-220
NDC 1072603-220-10
NDC Item72603022010
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72603-220-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 72603-220

NDC Item 82449051301

NDC 982449-513
NDC 1082449-513-01
NDC Item82449051301
Packaging1 VIAL in 1 CARTON (82449-513-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 82449051302

NDC 982449-513
NDC 1082449-513-02
NDC Item82449051302
Packaging10 VIAL in 1 CARTON (82449-513-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 00409268901

NDC 90409-2689
NDC 100409-2689-01
NDC Item00409268901
Packaging10 VIAL in 1 TRAY (0409-2689-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0409-2689-21)
ANDAANDA065310
FDA SPL set id806154
LabelerHospira, Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-07-25
Marketing statusACTIVE
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268921

NDC 90409-2689
NDC 100409-2689-21
NDC Item00409268921
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268949

NDC 90409-2689
NDC 100409-2689-49
NDC Item00409268949
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00641611601

NDC 90641-6116
NDC 100641-6116-01
NDC Item00641611601
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611610

NDC 90641-6116
NDC 100641-6116-10
NDC Item00641611610
Packaging10 VIAL in 1 CARTON (0641-6116-10) / 1.5 g in 1 VIAL (0641-6116-01)
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611901

NDC 90641-6119
NDC 100641-6119-01
NDC Item00641611901
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641611910

NDC 90641-6119
NDC 100641-6119-10
NDC Item00641611910
Packaging10 VIAL in 1 CARTON (0641-6119-10) / 1.5 g in 1 VIAL (0641-6119-01)
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641612201

NDC 90641-6122
NDC 100641-6122-01
NDC Item00641612201
Packaging4 mL in 1 VIAL
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00641612210

NDC 90641-6122
NDC 100641-6122-10
NDC Item00641612210
Packaging10 VIAL in 1 CARTON (0641-6122-10) / 4 mL in 1 VIAL (0641-6122-01)
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00781303270

NDC 90781-3032
NDC 100781-3032-70
NDC Item00781303270
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 00781303295

NDC 90781-3032
NDC 100781-3032-95
NDC Item00781303295
Packaging10 VIAL in 1 CARTON (0781-3032-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-3032-70)
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 25021014220

NDC 925021-142
NDC 1025021-142-20
NDC Item25021014220
Packaging10 VIAL in 1 CARTON (25021-142-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065406
FDA SPL set id612973
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-06-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 25021-142

NDC Item 25021018620

NDC 925021-186
NDC 1025021-186-20
NDC Item25021018620
Packaging10 VIAL in 1 CARTON (25021-186-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090579
FDA SPL set id549185
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-03-31
Marketing effective time low2017-08-15
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 25021-186

NDC Item 44567021010

NDC 944567-210
NDC 1044567-210-10
NDC Item44567021010
Packaging10 VIAL in 1 CARTON (44567-210-10) / 10 mL in 1 VIAL
ANDAANDA065176
FDA SPL set id803837
LabelerWG Critical Care, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 44567-210

NDC Item 55150011601

NDC 955150-116
NDC 1055150-116-01
NDC Item55150011601
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011610

NDC 955150-116
NDC 1055150-116-10
NDC Item55150011610
Packaging10 VIAL in 1 CARTON (55150-116-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011620

NDC 955150-116
NDC 1055150-116-20
NDC Item55150011620
Packaging10 VIAL in 1 CARTON (55150-116-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150017899

NDC 955150-178
NDC 1055150-178-99
NDC Item55150017899
Packaging10 BOTTLE in 1 BOX (55150-178-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE
ANDAANDA090340
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-09-13
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-178

NDC Item 63323036820

NDC 963323-368
NDC 1063323-368-20
NDC Item63323036820
Packaging10 VIAL in 1 CARTON (63323-368-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065222
FDA SPL set id460623
LabelerFresenius Kabi USA, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2016-05-05
Marketing effective time low2005-11-29
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 63323-368

NDC Item 66794020602

NDC 966794-206
NDC 1066794-206-02
NDC Item66794020602
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794020641

NDC 966794-206
NDC 1066794-206-41
NDC Item66794020641
Packaging10 VIAL in 1 CARTON (66794-206-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-206-02)
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794024102

NDC 966794-241
NDC 1066794-241-02
NDC Item66794024102
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 66794024141

NDC 966794-241
NDC 1066794-241-41
NDC Item66794024141
Packaging10 VIAL in 1 CARTON (66794-241-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-241-02)
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 67457034810

NDC 967457-348
NDC 1067457-348-10
NDC Item67457034810
Packaging10 VIAL in 1 CARTON (67457-348-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67457034815

NDC 967457-348
NDC 1067457-348-15
NDC Item67457034815
Packaging1 VIAL in 1 CARTON (67457-348-15) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67850013000

NDC 967850-130
NDC 1067850-130-00
NDC Item67850013000
Packaging1 in 1 VIAL, GLASS
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 67850013010

NDC 967850-130
NDC 1067850-130-10
NDC Item67850013010
Packaging10 VIAL, GLASS in 1 CARTON (67850-130-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (67850-130-00)
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 70594008101

NDC 970594-081
NDC 1070594-081-01
NDC Item70594008101
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 70594008102

NDC 970594-081
NDC 1070594-081-02
NDC Item70594008102
Packaging10 VIAL in 1 CARTON (70594-081-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-081-01)
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 71288000520

NDC 971288-005
NDC 1071288-005-20
NDC Item71288000520
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-005-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-005-21)
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288000521

NDC 971288-005
NDC 1071288-005-21
NDC Item71288000521
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288003120

NDC 971288-031
NDC 1071288-031-20
NDC Item71288003120
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003121

NDC 971288-031
NDC 1071288-031-21
NDC Item71288003121
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-21) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-20)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003191

NDC 971288-031
NDC 1071288-031-91
NDC Item71288003191
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003192

NDC 971288-031
NDC 1071288-031-92
NDC Item71288003192
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-92) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-91)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 72485041601

NDC 972485-416
NDC 1072485-416-01
NDC Item72485041601
Packaging1 in 1 VIAL
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72485041610

NDC 972485-416
NDC 1072485-416-10
NDC Item72485041610
Packaging10 VIAL in 1 CARTON (72485-416-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72485-416-01)
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72572002101

NDC 972572-021
NDC 1072572-021-01
NDC Item72572002101
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72572002110

NDC 972572-021
NDC 1072572-021-10
NDC Item72572002110
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72572-021-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72572-021-01)
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72603022001

NDC 972603-220
NDC 1072603-220-01
NDC Item72603022001
Packaging1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusactive
Related queriesProperties for NDC 9 72603-220

NDC Item 72603022010

NDC 972603-220
NDC 1072603-220-10
NDC Item72603022010
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72603-220-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 72603-220

NDC Item 82449051301

NDC 982449-513
NDC 1082449-513-01
NDC Item82449051301
Packaging1 VIAL in 1 CARTON (82449-513-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 82449051302

NDC 982449-513
NDC 1082449-513-02
NDC Item82449051302
Packaging10 VIAL in 1 CARTON (82449-513-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 00409268901

NDC 90409-2689
NDC 100409-2689-01
NDC Item00409268901
Packaging10 VIAL in 1 TRAY (0409-2689-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0409-2689-21)
ANDAANDA065310
FDA SPL set id806154
LabelerHospira, Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-07-25
Marketing statusACTIVE
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268921

NDC 90409-2689
NDC 100409-2689-21
NDC Item00409268921
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268949

NDC 90409-2689
NDC 100409-2689-49
NDC Item00409268949
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00641611601

NDC 90641-6116
NDC 100641-6116-01
NDC Item00641611601
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611610

NDC 90641-6116
NDC 100641-6116-10
NDC Item00641611610
Packaging10 VIAL in 1 CARTON (0641-6116-10) / 1.5 g in 1 VIAL (0641-6116-01)
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611901

NDC 90641-6119
NDC 100641-6119-01
NDC Item00641611901
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641611910

NDC 90641-6119
NDC 100641-6119-10
NDC Item00641611910
Packaging10 VIAL in 1 CARTON (0641-6119-10) / 1.5 g in 1 VIAL (0641-6119-01)
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641612201

NDC 90641-6122
NDC 100641-6122-01
NDC Item00641612201
Packaging4 mL in 1 VIAL
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00641612210

NDC 90641-6122
NDC 100641-6122-10
NDC Item00641612210
Packaging10 VIAL in 1 CARTON (0641-6122-10) / 4 mL in 1 VIAL (0641-6122-01)
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00781303270

NDC 90781-3032
NDC 100781-3032-70
NDC Item00781303270
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 00781303295

NDC 90781-3032
NDC 100781-3032-95
NDC Item00781303295
Packaging10 VIAL in 1 CARTON (0781-3032-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-3032-70)
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 25021014220

NDC 925021-142
NDC 1025021-142-20
NDC Item25021014220
Packaging10 VIAL in 1 CARTON (25021-142-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065406
FDA SPL set id612973
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-06-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 25021-142

NDC Item 25021018620

NDC 925021-186
NDC 1025021-186-20
NDC Item25021018620
Packaging10 VIAL in 1 CARTON (25021-186-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090579
FDA SPL set id549185
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-03-31
Marketing effective time low2017-08-15
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 25021-186

NDC Item 44567021010

NDC 944567-210
NDC 1044567-210-10
NDC Item44567021010
Packaging10 VIAL in 1 CARTON (44567-210-10) / 10 mL in 1 VIAL
ANDAANDA065176
FDA SPL set id803837
LabelerWG Critical Care, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 44567-210

NDC Item 55150011601

NDC 955150-116
NDC 1055150-116-01
NDC Item55150011601
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011610

NDC 955150-116
NDC 1055150-116-10
NDC Item55150011610
Packaging10 VIAL in 1 CARTON (55150-116-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011620

NDC 955150-116
NDC 1055150-116-20
NDC Item55150011620
Packaging10 VIAL in 1 CARTON (55150-116-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150017899

NDC 955150-178
NDC 1055150-178-99
NDC Item55150017899
Packaging10 BOTTLE in 1 BOX (55150-178-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE
ANDAANDA090340
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-09-13
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-178

NDC Item 63323036820

NDC 963323-368
NDC 1063323-368-20
NDC Item63323036820
Packaging10 VIAL in 1 CARTON (63323-368-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065222
FDA SPL set id460623
LabelerFresenius Kabi USA, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2016-05-05
Marketing effective time low2005-11-29
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 63323-368

NDC Item 66794020602

NDC 966794-206
NDC 1066794-206-02
NDC Item66794020602
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794020641

NDC 966794-206
NDC 1066794-206-41
NDC Item66794020641
Packaging10 VIAL in 1 CARTON (66794-206-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-206-02)
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794024102

NDC 966794-241
NDC 1066794-241-02
NDC Item66794024102
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 66794024141

NDC 966794-241
NDC 1066794-241-41
NDC Item66794024141
Packaging10 VIAL in 1 CARTON (66794-241-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-241-02)
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 67457034810

NDC 967457-348
NDC 1067457-348-10
NDC Item67457034810
Packaging10 VIAL in 1 CARTON (67457-348-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67457034815

NDC 967457-348
NDC 1067457-348-15
NDC Item67457034815
Packaging1 VIAL in 1 CARTON (67457-348-15) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67850013000

NDC 967850-130
NDC 1067850-130-00
NDC Item67850013000
Packaging1 in 1 VIAL, GLASS
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 67850013010

NDC 967850-130
NDC 1067850-130-10
NDC Item67850013010
Packaging10 VIAL, GLASS in 1 CARTON (67850-130-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (67850-130-00)
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 70594008101

NDC 970594-081
NDC 1070594-081-01
NDC Item70594008101
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 70594008102

NDC 970594-081
NDC 1070594-081-02
NDC Item70594008102
Packaging10 VIAL in 1 CARTON (70594-081-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-081-01)
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 71288000520

NDC 971288-005
NDC 1071288-005-20
NDC Item71288000520
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-005-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-005-21)
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288000521

NDC 971288-005
NDC 1071288-005-21
NDC Item71288000521
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288003120

NDC 971288-031
NDC 1071288-031-20
NDC Item71288003120
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003121

NDC 971288-031
NDC 1071288-031-21
NDC Item71288003121
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-21) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-20)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003191

NDC 971288-031
NDC 1071288-031-91
NDC Item71288003191
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003192

NDC 971288-031
NDC 1071288-031-92
NDC Item71288003192
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-92) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-91)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 72485041601

NDC 972485-416
NDC 1072485-416-01
NDC Item72485041601
Packaging1 in 1 VIAL
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72485041610

NDC 972485-416
NDC 1072485-416-10
NDC Item72485041610
Packaging10 VIAL in 1 CARTON (72485-416-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72485-416-01)
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72572002101

NDC 972572-021
NDC 1072572-021-01
NDC Item72572002101
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72572002110

NDC 972572-021
NDC 1072572-021-10
NDC Item72572002110
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72572-021-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72572-021-01)
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72603022001

NDC 972603-220
NDC 1072603-220-01
NDC Item72603022001
Packaging1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusactive
Related queriesProperties for NDC 9 72603-220

NDC Item 72603022010

NDC 972603-220
NDC 1072603-220-10
NDC Item72603022010
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72603-220-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 72603-220

NDC Item 82449051301

NDC 982449-513
NDC 1082449-513-01
NDC Item82449051301
Packaging1 VIAL in 1 CARTON (82449-513-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 82449051302

NDC 982449-513
NDC 1082449-513-02
NDC Item82449051302
Packaging10 VIAL in 1 CARTON (82449-513-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 00409268901

NDC 90409-2689
NDC 100409-2689-01
NDC Item00409268901
Packaging10 VIAL in 1 TRAY (0409-2689-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0409-2689-21)
ANDAANDA065310
FDA SPL set id806154
LabelerHospira, Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-07-25
Marketing statusACTIVE
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268921

NDC 90409-2689
NDC 100409-2689-21
NDC Item00409268921
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268949

NDC 90409-2689
NDC 100409-2689-49
NDC Item00409268949
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00641611601

NDC 90641-6116
NDC 100641-6116-01
NDC Item00641611601
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611610

NDC 90641-6116
NDC 100641-6116-10
NDC Item00641611610
Packaging10 VIAL in 1 CARTON (0641-6116-10) / 1.5 g in 1 VIAL (0641-6116-01)
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611901

NDC 90641-6119
NDC 100641-6119-01
NDC Item00641611901
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641611910

NDC 90641-6119
NDC 100641-6119-10
NDC Item00641611910
Packaging10 VIAL in 1 CARTON (0641-6119-10) / 1.5 g in 1 VIAL (0641-6119-01)
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641612201

NDC 90641-6122
NDC 100641-6122-01
NDC Item00641612201
Packaging4 mL in 1 VIAL
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00641612210

NDC 90641-6122
NDC 100641-6122-10
NDC Item00641612210
Packaging10 VIAL in 1 CARTON (0641-6122-10) / 4 mL in 1 VIAL (0641-6122-01)
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00781303270

NDC 90781-3032
NDC 100781-3032-70
NDC Item00781303270
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 00781303295

NDC 90781-3032
NDC 100781-3032-95
NDC Item00781303295
Packaging10 VIAL in 1 CARTON (0781-3032-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-3032-70)
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 25021014220

NDC 925021-142
NDC 1025021-142-20
NDC Item25021014220
Packaging10 VIAL in 1 CARTON (25021-142-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065406
FDA SPL set id612973
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-06-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 25021-142

NDC Item 25021018620

NDC 925021-186
NDC 1025021-186-20
NDC Item25021018620
Packaging10 VIAL in 1 CARTON (25021-186-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090579
FDA SPL set id549185
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-03-31
Marketing effective time low2017-08-15
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 25021-186

NDC Item 44567021010

NDC 944567-210
NDC 1044567-210-10
NDC Item44567021010
Packaging10 VIAL in 1 CARTON (44567-210-10) / 10 mL in 1 VIAL
ANDAANDA065176
FDA SPL set id803837
LabelerWG Critical Care, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 44567-210

NDC Item 55150011601

NDC 955150-116
NDC 1055150-116-01
NDC Item55150011601
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011610

NDC 955150-116
NDC 1055150-116-10
NDC Item55150011610
Packaging10 VIAL in 1 CARTON (55150-116-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011620

NDC 955150-116
NDC 1055150-116-20
NDC Item55150011620
Packaging10 VIAL in 1 CARTON (55150-116-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150017899

NDC 955150-178
NDC 1055150-178-99
NDC Item55150017899
Packaging10 BOTTLE in 1 BOX (55150-178-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE
ANDAANDA090340
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-09-13
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-178

NDC Item 63323036820

NDC 963323-368
NDC 1063323-368-20
NDC Item63323036820
Packaging10 VIAL in 1 CARTON (63323-368-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065222
FDA SPL set id460623
LabelerFresenius Kabi USA, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2016-05-05
Marketing effective time low2005-11-29
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 63323-368

NDC Item 66794020602

NDC 966794-206
NDC 1066794-206-02
NDC Item66794020602
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794020641

NDC 966794-206
NDC 1066794-206-41
NDC Item66794020641
Packaging10 VIAL in 1 CARTON (66794-206-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-206-02)
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794024102

NDC 966794-241
NDC 1066794-241-02
NDC Item66794024102
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 66794024141

NDC 966794-241
NDC 1066794-241-41
NDC Item66794024141
Packaging10 VIAL in 1 CARTON (66794-241-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-241-02)
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 67457034810

NDC 967457-348
NDC 1067457-348-10
NDC Item67457034810
Packaging10 VIAL in 1 CARTON (67457-348-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67457034815

NDC 967457-348
NDC 1067457-348-15
NDC Item67457034815
Packaging1 VIAL in 1 CARTON (67457-348-15) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67850013000

NDC 967850-130
NDC 1067850-130-00
NDC Item67850013000
Packaging1 in 1 VIAL, GLASS
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 67850013010

NDC 967850-130
NDC 1067850-130-10
NDC Item67850013010
Packaging10 VIAL, GLASS in 1 CARTON (67850-130-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (67850-130-00)
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 70594008101

NDC 970594-081
NDC 1070594-081-01
NDC Item70594008101
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 70594008102

NDC 970594-081
NDC 1070594-081-02
NDC Item70594008102
Packaging10 VIAL in 1 CARTON (70594-081-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-081-01)
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 71288000520

NDC 971288-005
NDC 1071288-005-20
NDC Item71288000520
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-005-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-005-21)
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288000521

NDC 971288-005
NDC 1071288-005-21
NDC Item71288000521
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288003120

NDC 971288-031
NDC 1071288-031-20
NDC Item71288003120
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003121

NDC 971288-031
NDC 1071288-031-21
NDC Item71288003121
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-21) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-20)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003191

NDC 971288-031
NDC 1071288-031-91
NDC Item71288003191
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003192

NDC 971288-031
NDC 1071288-031-92
NDC Item71288003192
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-92) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-91)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 72485041601

NDC 972485-416
NDC 1072485-416-01
NDC Item72485041601
Packaging1 in 1 VIAL
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72485041610

NDC 972485-416
NDC 1072485-416-10
NDC Item72485041610
Packaging10 VIAL in 1 CARTON (72485-416-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72485-416-01)
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72572002101

NDC 972572-021
NDC 1072572-021-01
NDC Item72572002101
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72572002110

NDC 972572-021
NDC 1072572-021-10
NDC Item72572002110
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72572-021-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72572-021-01)
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72603022001

NDC 972603-220
NDC 1072603-220-01
NDC Item72603022001
Packaging1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusactive
Related queriesProperties for NDC 9 72603-220

NDC Item 72603022010

NDC 972603-220
NDC 1072603-220-10
NDC Item72603022010
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72603-220-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 72603-220

NDC Item 82449051301

NDC 982449-513
NDC 1082449-513-01
NDC Item82449051301
Packaging1 VIAL in 1 CARTON (82449-513-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 82449051302

NDC 982449-513
NDC 1082449-513-02
NDC Item82449051302
Packaging10 VIAL in 1 CARTON (82449-513-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 00409268901

NDC 90409-2689
NDC 100409-2689-01
NDC Item00409268901
Packaging10 VIAL in 1 TRAY (0409-2689-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0409-2689-21)
ANDAANDA065310
FDA SPL set id806154
LabelerHospira, Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-07-25
Marketing statusACTIVE
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268921

NDC 90409-2689
NDC 100409-2689-21
NDC Item00409268921
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268949

NDC 90409-2689
NDC 100409-2689-49
NDC Item00409268949
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00641611601

NDC 90641-6116
NDC 100641-6116-01
NDC Item00641611601
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611610

NDC 90641-6116
NDC 100641-6116-10
NDC Item00641611610
Packaging10 VIAL in 1 CARTON (0641-6116-10) / 1.5 g in 1 VIAL (0641-6116-01)
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611901

NDC 90641-6119
NDC 100641-6119-01
NDC Item00641611901
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641611910

NDC 90641-6119
NDC 100641-6119-10
NDC Item00641611910
Packaging10 VIAL in 1 CARTON (0641-6119-10) / 1.5 g in 1 VIAL (0641-6119-01)
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641612201

NDC 90641-6122
NDC 100641-6122-01
NDC Item00641612201
Packaging4 mL in 1 VIAL
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00641612210

NDC 90641-6122
NDC 100641-6122-10
NDC Item00641612210
Packaging10 VIAL in 1 CARTON (0641-6122-10) / 4 mL in 1 VIAL (0641-6122-01)
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00781303270

NDC 90781-3032
NDC 100781-3032-70
NDC Item00781303270
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 00781303295

NDC 90781-3032
NDC 100781-3032-95
NDC Item00781303295
Packaging10 VIAL in 1 CARTON (0781-3032-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-3032-70)
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 25021014220

NDC 925021-142
NDC 1025021-142-20
NDC Item25021014220
Packaging10 VIAL in 1 CARTON (25021-142-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065406
FDA SPL set id612973
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-06-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 25021-142

NDC Item 25021018620

NDC 925021-186
NDC 1025021-186-20
NDC Item25021018620
Packaging10 VIAL in 1 CARTON (25021-186-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090579
FDA SPL set id549185
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-03-31
Marketing effective time low2017-08-15
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 25021-186

NDC Item 44567021010

NDC 944567-210
NDC 1044567-210-10
NDC Item44567021010
Packaging10 VIAL in 1 CARTON (44567-210-10) / 10 mL in 1 VIAL
ANDAANDA065176
FDA SPL set id803837
LabelerWG Critical Care, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 44567-210

NDC Item 55150011601

NDC 955150-116
NDC 1055150-116-01
NDC Item55150011601
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011610

NDC 955150-116
NDC 1055150-116-10
NDC Item55150011610
Packaging10 VIAL in 1 CARTON (55150-116-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011620

NDC 955150-116
NDC 1055150-116-20
NDC Item55150011620
Packaging10 VIAL in 1 CARTON (55150-116-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150017899

NDC 955150-178
NDC 1055150-178-99
NDC Item55150017899
Packaging10 BOTTLE in 1 BOX (55150-178-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE
ANDAANDA090340
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-09-13
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-178

NDC Item 63323036820

NDC 963323-368
NDC 1063323-368-20
NDC Item63323036820
Packaging10 VIAL in 1 CARTON (63323-368-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065222
FDA SPL set id460623
LabelerFresenius Kabi USA, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2016-05-05
Marketing effective time low2005-11-29
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 63323-368

NDC Item 66794020602

NDC 966794-206
NDC 1066794-206-02
NDC Item66794020602
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794020641

NDC 966794-206
NDC 1066794-206-41
NDC Item66794020641
Packaging10 VIAL in 1 CARTON (66794-206-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-206-02)
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794024102

NDC 966794-241
NDC 1066794-241-02
NDC Item66794024102
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 66794024141

NDC 966794-241
NDC 1066794-241-41
NDC Item66794024141
Packaging10 VIAL in 1 CARTON (66794-241-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-241-02)
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 67457034810

NDC 967457-348
NDC 1067457-348-10
NDC Item67457034810
Packaging10 VIAL in 1 CARTON (67457-348-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67457034815

NDC 967457-348
NDC 1067457-348-15
NDC Item67457034815
Packaging1 VIAL in 1 CARTON (67457-348-15) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67850013000

NDC 967850-130
NDC 1067850-130-00
NDC Item67850013000
Packaging1 in 1 VIAL, GLASS
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 67850013010

NDC 967850-130
NDC 1067850-130-10
NDC Item67850013010
Packaging10 VIAL, GLASS in 1 CARTON (67850-130-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (67850-130-00)
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 70594008101

NDC 970594-081
NDC 1070594-081-01
NDC Item70594008101
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 70594008102

NDC 970594-081
NDC 1070594-081-02
NDC Item70594008102
Packaging10 VIAL in 1 CARTON (70594-081-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-081-01)
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 71288000520

NDC 971288-005
NDC 1071288-005-20
NDC Item71288000520
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-005-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-005-21)
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288000521

NDC 971288-005
NDC 1071288-005-21
NDC Item71288000521
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288003120

NDC 971288-031
NDC 1071288-031-20
NDC Item71288003120
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003121

NDC 971288-031
NDC 1071288-031-21
NDC Item71288003121
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-21) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-20)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003191

NDC 971288-031
NDC 1071288-031-91
NDC Item71288003191
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003192

NDC 971288-031
NDC 1071288-031-92
NDC Item71288003192
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-92) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-91)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 72485041601

NDC 972485-416
NDC 1072485-416-01
NDC Item72485041601
Packaging1 in 1 VIAL
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72485041610

NDC 972485-416
NDC 1072485-416-10
NDC Item72485041610
Packaging10 VIAL in 1 CARTON (72485-416-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72485-416-01)
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72572002101

NDC 972572-021
NDC 1072572-021-01
NDC Item72572002101
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72572002110

NDC 972572-021
NDC 1072572-021-10
NDC Item72572002110
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72572-021-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72572-021-01)
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72603022001

NDC 972603-220
NDC 1072603-220-01
NDC Item72603022001
Packaging1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusactive
Related queriesProperties for NDC 9 72603-220

NDC Item 72603022010

NDC 972603-220
NDC 1072603-220-10
NDC Item72603022010
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72603-220-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 72603-220

NDC Item 82449051301

NDC 982449-513
NDC 1082449-513-01
NDC Item82449051301
Packaging1 VIAL in 1 CARTON (82449-513-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 82449051302

NDC 982449-513
NDC 1082449-513-02
NDC Item82449051302
Packaging10 VIAL in 1 CARTON (82449-513-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 00409268901

NDC 90409-2689
NDC 100409-2689-01
NDC Item00409268901
Packaging10 VIAL in 1 TRAY (0409-2689-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0409-2689-21)
ANDAANDA065310
FDA SPL set id806154
LabelerHospira, Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-07-25
Marketing statusACTIVE
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268921

NDC 90409-2689
NDC 100409-2689-21
NDC Item00409268921
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268949

NDC 90409-2689
NDC 100409-2689-49
NDC Item00409268949
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00641611601

NDC 90641-6116
NDC 100641-6116-01
NDC Item00641611601
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611610

NDC 90641-6116
NDC 100641-6116-10
NDC Item00641611610
Packaging10 VIAL in 1 CARTON (0641-6116-10) / 1.5 g in 1 VIAL (0641-6116-01)
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611901

NDC 90641-6119
NDC 100641-6119-01
NDC Item00641611901
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641611910

NDC 90641-6119
NDC 100641-6119-10
NDC Item00641611910
Packaging10 VIAL in 1 CARTON (0641-6119-10) / 1.5 g in 1 VIAL (0641-6119-01)
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641612201

NDC 90641-6122
NDC 100641-6122-01
NDC Item00641612201
Packaging4 mL in 1 VIAL
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00641612210

NDC 90641-6122
NDC 100641-6122-10
NDC Item00641612210
Packaging10 VIAL in 1 CARTON (0641-6122-10) / 4 mL in 1 VIAL (0641-6122-01)
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00781303270

NDC 90781-3032
NDC 100781-3032-70
NDC Item00781303270
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 00781303295

NDC 90781-3032
NDC 100781-3032-95
NDC Item00781303295
Packaging10 VIAL in 1 CARTON (0781-3032-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-3032-70)
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 25021014220

NDC 925021-142
NDC 1025021-142-20
NDC Item25021014220
Packaging10 VIAL in 1 CARTON (25021-142-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065406
FDA SPL set id612973
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-06-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 25021-142

NDC Item 25021018620

NDC 925021-186
NDC 1025021-186-20
NDC Item25021018620
Packaging10 VIAL in 1 CARTON (25021-186-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090579
FDA SPL set id549185
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-03-31
Marketing effective time low2017-08-15
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 25021-186

NDC Item 44567021010

NDC 944567-210
NDC 1044567-210-10
NDC Item44567021010
Packaging10 VIAL in 1 CARTON (44567-210-10) / 10 mL in 1 VIAL
ANDAANDA065176
FDA SPL set id803837
LabelerWG Critical Care, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 44567-210

NDC Item 55150011601

NDC 955150-116
NDC 1055150-116-01
NDC Item55150011601
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011610

NDC 955150-116
NDC 1055150-116-10
NDC Item55150011610
Packaging10 VIAL in 1 CARTON (55150-116-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011620

NDC 955150-116
NDC 1055150-116-20
NDC Item55150011620
Packaging10 VIAL in 1 CARTON (55150-116-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150017899

NDC 955150-178
NDC 1055150-178-99
NDC Item55150017899
Packaging10 BOTTLE in 1 BOX (55150-178-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE
ANDAANDA090340
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-09-13
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-178

NDC Item 63323036820

NDC 963323-368
NDC 1063323-368-20
NDC Item63323036820
Packaging10 VIAL in 1 CARTON (63323-368-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065222
FDA SPL set id460623
LabelerFresenius Kabi USA, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2016-05-05
Marketing effective time low2005-11-29
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 63323-368

NDC Item 66794020602

NDC 966794-206
NDC 1066794-206-02
NDC Item66794020602
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794020641

NDC 966794-206
NDC 1066794-206-41
NDC Item66794020641
Packaging10 VIAL in 1 CARTON (66794-206-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-206-02)
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794024102

NDC 966794-241
NDC 1066794-241-02
NDC Item66794024102
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 66794024141

NDC 966794-241
NDC 1066794-241-41
NDC Item66794024141
Packaging10 VIAL in 1 CARTON (66794-241-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-241-02)
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 67457034810

NDC 967457-348
NDC 1067457-348-10
NDC Item67457034810
Packaging10 VIAL in 1 CARTON (67457-348-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67457034815

NDC 967457-348
NDC 1067457-348-15
NDC Item67457034815
Packaging1 VIAL in 1 CARTON (67457-348-15) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67850013000

NDC 967850-130
NDC 1067850-130-00
NDC Item67850013000
Packaging1 in 1 VIAL, GLASS
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 67850013010

NDC 967850-130
NDC 1067850-130-10
NDC Item67850013010
Packaging10 VIAL, GLASS in 1 CARTON (67850-130-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (67850-130-00)
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 70594008101

NDC 970594-081
NDC 1070594-081-01
NDC Item70594008101
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 70594008102

NDC 970594-081
NDC 1070594-081-02
NDC Item70594008102
Packaging10 VIAL in 1 CARTON (70594-081-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-081-01)
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 71288000520

NDC 971288-005
NDC 1071288-005-20
NDC Item71288000520
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-005-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-005-21)
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288000521

NDC 971288-005
NDC 1071288-005-21
NDC Item71288000521
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288003120

NDC 971288-031
NDC 1071288-031-20
NDC Item71288003120
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003121

NDC 971288-031
NDC 1071288-031-21
NDC Item71288003121
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-21) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-20)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003191

NDC 971288-031
NDC 1071288-031-91
NDC Item71288003191
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003192

NDC 971288-031
NDC 1071288-031-92
NDC Item71288003192
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-92) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-91)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 72485041601

NDC 972485-416
NDC 1072485-416-01
NDC Item72485041601
Packaging1 in 1 VIAL
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72485041610

NDC 972485-416
NDC 1072485-416-10
NDC Item72485041610
Packaging10 VIAL in 1 CARTON (72485-416-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72485-416-01)
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72572002101

NDC 972572-021
NDC 1072572-021-01
NDC Item72572002101
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72572002110

NDC 972572-021
NDC 1072572-021-10
NDC Item72572002110
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72572-021-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72572-021-01)
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72603022001

NDC 972603-220
NDC 1072603-220-01
NDC Item72603022001
Packaging1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusactive
Related queriesProperties for NDC 9 72603-220

NDC Item 72603022010

NDC 972603-220
NDC 1072603-220-10
NDC Item72603022010
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72603-220-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 72603-220

NDC Item 82449051301

NDC 982449-513
NDC 1082449-513-01
NDC Item82449051301
Packaging1 VIAL in 1 CARTON (82449-513-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 82449051302

NDC 982449-513
NDC 1082449-513-02
NDC Item82449051302
Packaging10 VIAL in 1 CARTON (82449-513-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 00409268901

NDC 90409-2689
NDC 100409-2689-01
NDC Item00409268901
Packaging10 VIAL in 1 TRAY (0409-2689-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0409-2689-21)
ANDAANDA065310
FDA SPL set id806154
LabelerHospira, Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-07-25
Marketing statusACTIVE
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268921

NDC 90409-2689
NDC 100409-2689-21
NDC Item00409268921
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268949

NDC 90409-2689
NDC 100409-2689-49
NDC Item00409268949
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00641611601

NDC 90641-6116
NDC 100641-6116-01
NDC Item00641611601
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611610

NDC 90641-6116
NDC 100641-6116-10
NDC Item00641611610
Packaging10 VIAL in 1 CARTON (0641-6116-10) / 1.5 g in 1 VIAL (0641-6116-01)
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611901

NDC 90641-6119
NDC 100641-6119-01
NDC Item00641611901
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641611910

NDC 90641-6119
NDC 100641-6119-10
NDC Item00641611910
Packaging10 VIAL in 1 CARTON (0641-6119-10) / 1.5 g in 1 VIAL (0641-6119-01)
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641612201

NDC 90641-6122
NDC 100641-6122-01
NDC Item00641612201
Packaging4 mL in 1 VIAL
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00641612210

NDC 90641-6122
NDC 100641-6122-10
NDC Item00641612210
Packaging10 VIAL in 1 CARTON (0641-6122-10) / 4 mL in 1 VIAL (0641-6122-01)
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00781303270

NDC 90781-3032
NDC 100781-3032-70
NDC Item00781303270
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 00781303295

NDC 90781-3032
NDC 100781-3032-95
NDC Item00781303295
Packaging10 VIAL in 1 CARTON (0781-3032-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-3032-70)
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 25021014220

NDC 925021-142
NDC 1025021-142-20
NDC Item25021014220
Packaging10 VIAL in 1 CARTON (25021-142-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065406
FDA SPL set id612973
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-06-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 25021-142

NDC Item 25021018620

NDC 925021-186
NDC 1025021-186-20
NDC Item25021018620
Packaging10 VIAL in 1 CARTON (25021-186-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090579
FDA SPL set id549185
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-03-31
Marketing effective time low2017-08-15
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 25021-186

NDC Item 44567021010

NDC 944567-210
NDC 1044567-210-10
NDC Item44567021010
Packaging10 VIAL in 1 CARTON (44567-210-10) / 10 mL in 1 VIAL
ANDAANDA065176
FDA SPL set id803837
LabelerWG Critical Care, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 44567-210

NDC Item 55150011601

NDC 955150-116
NDC 1055150-116-01
NDC Item55150011601
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011610

NDC 955150-116
NDC 1055150-116-10
NDC Item55150011610
Packaging10 VIAL in 1 CARTON (55150-116-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011620

NDC 955150-116
NDC 1055150-116-20
NDC Item55150011620
Packaging10 VIAL in 1 CARTON (55150-116-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150017899

NDC 955150-178
NDC 1055150-178-99
NDC Item55150017899
Packaging10 BOTTLE in 1 BOX (55150-178-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE
ANDAANDA090340
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-09-13
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-178

NDC Item 63323036820

NDC 963323-368
NDC 1063323-368-20
NDC Item63323036820
Packaging10 VIAL in 1 CARTON (63323-368-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065222
FDA SPL set id460623
LabelerFresenius Kabi USA, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2016-05-05
Marketing effective time low2005-11-29
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 63323-368

NDC Item 66794020602

NDC 966794-206
NDC 1066794-206-02
NDC Item66794020602
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794020641

NDC 966794-206
NDC 1066794-206-41
NDC Item66794020641
Packaging10 VIAL in 1 CARTON (66794-206-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-206-02)
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794024102

NDC 966794-241
NDC 1066794-241-02
NDC Item66794024102
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 66794024141

NDC 966794-241
NDC 1066794-241-41
NDC Item66794024141
Packaging10 VIAL in 1 CARTON (66794-241-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-241-02)
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 67457034810

NDC 967457-348
NDC 1067457-348-10
NDC Item67457034810
Packaging10 VIAL in 1 CARTON (67457-348-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67457034815

NDC 967457-348
NDC 1067457-348-15
NDC Item67457034815
Packaging1 VIAL in 1 CARTON (67457-348-15) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67850013000

NDC 967850-130
NDC 1067850-130-00
NDC Item67850013000
Packaging1 in 1 VIAL, GLASS
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 67850013010

NDC 967850-130
NDC 1067850-130-10
NDC Item67850013010
Packaging10 VIAL, GLASS in 1 CARTON (67850-130-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (67850-130-00)
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 70594008101

NDC 970594-081
NDC 1070594-081-01
NDC Item70594008101
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 70594008102

NDC 970594-081
NDC 1070594-081-02
NDC Item70594008102
Packaging10 VIAL in 1 CARTON (70594-081-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-081-01)
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 71288000520

NDC 971288-005
NDC 1071288-005-20
NDC Item71288000520
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-005-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-005-21)
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288000521

NDC 971288-005
NDC 1071288-005-21
NDC Item71288000521
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288003120

NDC 971288-031
NDC 1071288-031-20
NDC Item71288003120
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003121

NDC 971288-031
NDC 1071288-031-21
NDC Item71288003121
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-21) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-20)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003191

NDC 971288-031
NDC 1071288-031-91
NDC Item71288003191
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003192

NDC 971288-031
NDC 1071288-031-92
NDC Item71288003192
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-92) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-91)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 72485041601

NDC 972485-416
NDC 1072485-416-01
NDC Item72485041601
Packaging1 in 1 VIAL
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72485041610

NDC 972485-416
NDC 1072485-416-10
NDC Item72485041610
Packaging10 VIAL in 1 CARTON (72485-416-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72485-416-01)
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72572002101

NDC 972572-021
NDC 1072572-021-01
NDC Item72572002101
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72572002110

NDC 972572-021
NDC 1072572-021-10
NDC Item72572002110
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72572-021-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72572-021-01)
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72603022001

NDC 972603-220
NDC 1072603-220-01
NDC Item72603022001
Packaging1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusactive
Related queriesProperties for NDC 9 72603-220

NDC Item 72603022010

NDC 972603-220
NDC 1072603-220-10
NDC Item72603022010
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72603-220-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 72603-220

NDC Item 82449051301

NDC 982449-513
NDC 1082449-513-01
NDC Item82449051301
Packaging1 VIAL in 1 CARTON (82449-513-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 82449051302

NDC 982449-513
NDC 1082449-513-02
NDC Item82449051302
Packaging10 VIAL in 1 CARTON (82449-513-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 00409268901

NDC 90409-2689
NDC 100409-2689-01
NDC Item00409268901
Packaging10 VIAL in 1 TRAY (0409-2689-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0409-2689-21)
ANDAANDA065310
FDA SPL set id806154
LabelerHospira, Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-07-25
Marketing statusACTIVE
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268921

NDC 90409-2689
NDC 100409-2689-21
NDC Item00409268921
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268949

NDC 90409-2689
NDC 100409-2689-49
NDC Item00409268949
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00641611601

NDC 90641-6116
NDC 100641-6116-01
NDC Item00641611601
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611610

NDC 90641-6116
NDC 100641-6116-10
NDC Item00641611610
Packaging10 VIAL in 1 CARTON (0641-6116-10) / 1.5 g in 1 VIAL (0641-6116-01)
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611901

NDC 90641-6119
NDC 100641-6119-01
NDC Item00641611901
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641611910

NDC 90641-6119
NDC 100641-6119-10
NDC Item00641611910
Packaging10 VIAL in 1 CARTON (0641-6119-10) / 1.5 g in 1 VIAL (0641-6119-01)
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641612201

NDC 90641-6122
NDC 100641-6122-01
NDC Item00641612201
Packaging4 mL in 1 VIAL
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00641612210

NDC 90641-6122
NDC 100641-6122-10
NDC Item00641612210
Packaging10 VIAL in 1 CARTON (0641-6122-10) / 4 mL in 1 VIAL (0641-6122-01)
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00781303270

NDC 90781-3032
NDC 100781-3032-70
NDC Item00781303270
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 00781303295

NDC 90781-3032
NDC 100781-3032-95
NDC Item00781303295
Packaging10 VIAL in 1 CARTON (0781-3032-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-3032-70)
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 25021014220

NDC 925021-142
NDC 1025021-142-20
NDC Item25021014220
Packaging10 VIAL in 1 CARTON (25021-142-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065406
FDA SPL set id612973
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-06-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 25021-142

NDC Item 25021018620

NDC 925021-186
NDC 1025021-186-20
NDC Item25021018620
Packaging10 VIAL in 1 CARTON (25021-186-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090579
FDA SPL set id549185
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-03-31
Marketing effective time low2017-08-15
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 25021-186

NDC Item 44567021010

NDC 944567-210
NDC 1044567-210-10
NDC Item44567021010
Packaging10 VIAL in 1 CARTON (44567-210-10) / 10 mL in 1 VIAL
ANDAANDA065176
FDA SPL set id803837
LabelerWG Critical Care, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 44567-210

NDC Item 55150011601

NDC 955150-116
NDC 1055150-116-01
NDC Item55150011601
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011610

NDC 955150-116
NDC 1055150-116-10
NDC Item55150011610
Packaging10 VIAL in 1 CARTON (55150-116-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011620

NDC 955150-116
NDC 1055150-116-20
NDC Item55150011620
Packaging10 VIAL in 1 CARTON (55150-116-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150017899

NDC 955150-178
NDC 1055150-178-99
NDC Item55150017899
Packaging10 BOTTLE in 1 BOX (55150-178-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE
ANDAANDA090340
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-09-13
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-178

NDC Item 63323036820

NDC 963323-368
NDC 1063323-368-20
NDC Item63323036820
Packaging10 VIAL in 1 CARTON (63323-368-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065222
FDA SPL set id460623
LabelerFresenius Kabi USA, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2016-05-05
Marketing effective time low2005-11-29
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 63323-368

NDC Item 66794020602

NDC 966794-206
NDC 1066794-206-02
NDC Item66794020602
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794020641

NDC 966794-206
NDC 1066794-206-41
NDC Item66794020641
Packaging10 VIAL in 1 CARTON (66794-206-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-206-02)
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794024102

NDC 966794-241
NDC 1066794-241-02
NDC Item66794024102
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 66794024141

NDC 966794-241
NDC 1066794-241-41
NDC Item66794024141
Packaging10 VIAL in 1 CARTON (66794-241-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-241-02)
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 67457034810

NDC 967457-348
NDC 1067457-348-10
NDC Item67457034810
Packaging10 VIAL in 1 CARTON (67457-348-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67457034815

NDC 967457-348
NDC 1067457-348-15
NDC Item67457034815
Packaging1 VIAL in 1 CARTON (67457-348-15) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67850013000

NDC 967850-130
NDC 1067850-130-00
NDC Item67850013000
Packaging1 in 1 VIAL, GLASS
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 67850013010

NDC 967850-130
NDC 1067850-130-10
NDC Item67850013010
Packaging10 VIAL, GLASS in 1 CARTON (67850-130-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (67850-130-00)
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 70594008101

NDC 970594-081
NDC 1070594-081-01
NDC Item70594008101
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 70594008102

NDC 970594-081
NDC 1070594-081-02
NDC Item70594008102
Packaging10 VIAL in 1 CARTON (70594-081-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-081-01)
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 71288000520

NDC 971288-005
NDC 1071288-005-20
NDC Item71288000520
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-005-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-005-21)
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288000521

NDC 971288-005
NDC 1071288-005-21
NDC Item71288000521
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288003120

NDC 971288-031
NDC 1071288-031-20
NDC Item71288003120
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003121

NDC 971288-031
NDC 1071288-031-21
NDC Item71288003121
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-21) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-20)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003191

NDC 971288-031
NDC 1071288-031-91
NDC Item71288003191
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003192

NDC 971288-031
NDC 1071288-031-92
NDC Item71288003192
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-92) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-91)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 72485041601

NDC 972485-416
NDC 1072485-416-01
NDC Item72485041601
Packaging1 in 1 VIAL
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72485041610

NDC 972485-416
NDC 1072485-416-10
NDC Item72485041610
Packaging10 VIAL in 1 CARTON (72485-416-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72485-416-01)
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72572002101

NDC 972572-021
NDC 1072572-021-01
NDC Item72572002101
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72572002110

NDC 972572-021
NDC 1072572-021-10
NDC Item72572002110
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72572-021-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72572-021-01)
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72603022001

NDC 972603-220
NDC 1072603-220-01
NDC Item72603022001
Packaging1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusactive
Related queriesProperties for NDC 9 72603-220

NDC Item 72603022010

NDC 972603-220
NDC 1072603-220-10
NDC Item72603022010
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72603-220-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 72603-220

NDC Item 82449051301

NDC 982449-513
NDC 1082449-513-01
NDC Item82449051301
Packaging1 VIAL in 1 CARTON (82449-513-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 82449051302

NDC 982449-513
NDC 1082449-513-02
NDC Item82449051302
Packaging10 VIAL in 1 CARTON (82449-513-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 00409268901

NDC 90409-2689
NDC 100409-2689-01
NDC Item00409268901
Packaging10 VIAL in 1 TRAY (0409-2689-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0409-2689-21)
ANDAANDA065310
FDA SPL set id806154
LabelerHospira, Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-07-25
Marketing statusACTIVE
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268921

NDC 90409-2689
NDC 100409-2689-21
NDC Item00409268921
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268949

NDC 90409-2689
NDC 100409-2689-49
NDC Item00409268949
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00641611601

NDC 90641-6116
NDC 100641-6116-01
NDC Item00641611601
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611610

NDC 90641-6116
NDC 100641-6116-10
NDC Item00641611610
Packaging10 VIAL in 1 CARTON (0641-6116-10) / 1.5 g in 1 VIAL (0641-6116-01)
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611901

NDC 90641-6119
NDC 100641-6119-01
NDC Item00641611901
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641611910

NDC 90641-6119
NDC 100641-6119-10
NDC Item00641611910
Packaging10 VIAL in 1 CARTON (0641-6119-10) / 1.5 g in 1 VIAL (0641-6119-01)
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641612201

NDC 90641-6122
NDC 100641-6122-01
NDC Item00641612201
Packaging4 mL in 1 VIAL
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00641612210

NDC 90641-6122
NDC 100641-6122-10
NDC Item00641612210
Packaging10 VIAL in 1 CARTON (0641-6122-10) / 4 mL in 1 VIAL (0641-6122-01)
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00781303270

NDC 90781-3032
NDC 100781-3032-70
NDC Item00781303270
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 00781303295

NDC 90781-3032
NDC 100781-3032-95
NDC Item00781303295
Packaging10 VIAL in 1 CARTON (0781-3032-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-3032-70)
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 25021014220

NDC 925021-142
NDC 1025021-142-20
NDC Item25021014220
Packaging10 VIAL in 1 CARTON (25021-142-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065406
FDA SPL set id612973
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-06-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 25021-142

NDC Item 25021018620

NDC 925021-186
NDC 1025021-186-20
NDC Item25021018620
Packaging10 VIAL in 1 CARTON (25021-186-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090579
FDA SPL set id549185
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-03-31
Marketing effective time low2017-08-15
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 25021-186

NDC Item 44567021010

NDC 944567-210
NDC 1044567-210-10
NDC Item44567021010
Packaging10 VIAL in 1 CARTON (44567-210-10) / 10 mL in 1 VIAL
ANDAANDA065176
FDA SPL set id803837
LabelerWG Critical Care, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 44567-210

NDC Item 55150011601

NDC 955150-116
NDC 1055150-116-01
NDC Item55150011601
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011610

NDC 955150-116
NDC 1055150-116-10
NDC Item55150011610
Packaging10 VIAL in 1 CARTON (55150-116-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011620

NDC 955150-116
NDC 1055150-116-20
NDC Item55150011620
Packaging10 VIAL in 1 CARTON (55150-116-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150017899

NDC 955150-178
NDC 1055150-178-99
NDC Item55150017899
Packaging10 BOTTLE in 1 BOX (55150-178-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE
ANDAANDA090340
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-09-13
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-178

NDC Item 63323036820

NDC 963323-368
NDC 1063323-368-20
NDC Item63323036820
Packaging10 VIAL in 1 CARTON (63323-368-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065222
FDA SPL set id460623
LabelerFresenius Kabi USA, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2016-05-05
Marketing effective time low2005-11-29
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 63323-368

NDC Item 66794020602

NDC 966794-206
NDC 1066794-206-02
NDC Item66794020602
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794020641

NDC 966794-206
NDC 1066794-206-41
NDC Item66794020641
Packaging10 VIAL in 1 CARTON (66794-206-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-206-02)
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794024102

NDC 966794-241
NDC 1066794-241-02
NDC Item66794024102
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 66794024141

NDC 966794-241
NDC 1066794-241-41
NDC Item66794024141
Packaging10 VIAL in 1 CARTON (66794-241-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-241-02)
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 67457034810

NDC 967457-348
NDC 1067457-348-10
NDC Item67457034810
Packaging10 VIAL in 1 CARTON (67457-348-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67457034815

NDC 967457-348
NDC 1067457-348-15
NDC Item67457034815
Packaging1 VIAL in 1 CARTON (67457-348-15) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67850013000

NDC 967850-130
NDC 1067850-130-00
NDC Item67850013000
Packaging1 in 1 VIAL, GLASS
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 67850013010

NDC 967850-130
NDC 1067850-130-10
NDC Item67850013010
Packaging10 VIAL, GLASS in 1 CARTON (67850-130-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (67850-130-00)
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 70594008101

NDC 970594-081
NDC 1070594-081-01
NDC Item70594008101
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 70594008102

NDC 970594-081
NDC 1070594-081-02
NDC Item70594008102
Packaging10 VIAL in 1 CARTON (70594-081-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-081-01)
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 71288000520

NDC 971288-005
NDC 1071288-005-20
NDC Item71288000520
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-005-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-005-21)
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288000521

NDC 971288-005
NDC 1071288-005-21
NDC Item71288000521
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288003120

NDC 971288-031
NDC 1071288-031-20
NDC Item71288003120
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003121

NDC 971288-031
NDC 1071288-031-21
NDC Item71288003121
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-21) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-20)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003191

NDC 971288-031
NDC 1071288-031-91
NDC Item71288003191
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003192

NDC 971288-031
NDC 1071288-031-92
NDC Item71288003192
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-92) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-91)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 72485041601

NDC 972485-416
NDC 1072485-416-01
NDC Item72485041601
Packaging1 in 1 VIAL
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72485041610

NDC 972485-416
NDC 1072485-416-10
NDC Item72485041610
Packaging10 VIAL in 1 CARTON (72485-416-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72485-416-01)
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72572002101

NDC 972572-021
NDC 1072572-021-01
NDC Item72572002101
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72572002110

NDC 972572-021
NDC 1072572-021-10
NDC Item72572002110
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72572-021-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72572-021-01)
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72603022001

NDC 972603-220
NDC 1072603-220-01
NDC Item72603022001
Packaging1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusactive
Related queriesProperties for NDC 9 72603-220

NDC Item 72603022010

NDC 972603-220
NDC 1072603-220-10
NDC Item72603022010
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72603-220-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 72603-220

NDC Item 82449051301

NDC 982449-513
NDC 1082449-513-01
NDC Item82449051301
Packaging1 VIAL in 1 CARTON (82449-513-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 82449051302

NDC 982449-513
NDC 1082449-513-02
NDC Item82449051302
Packaging10 VIAL in 1 CARTON (82449-513-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 00409268901

NDC 90409-2689
NDC 100409-2689-01
NDC Item00409268901
Packaging10 VIAL in 1 TRAY (0409-2689-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0409-2689-21)
ANDAANDA065310
FDA SPL set id806154
LabelerHospira, Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-07-25
Marketing statusACTIVE
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268921

NDC 90409-2689
NDC 100409-2689-21
NDC Item00409268921
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268949

NDC 90409-2689
NDC 100409-2689-49
NDC Item00409268949
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00641611601

NDC 90641-6116
NDC 100641-6116-01
NDC Item00641611601
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611610

NDC 90641-6116
NDC 100641-6116-10
NDC Item00641611610
Packaging10 VIAL in 1 CARTON (0641-6116-10) / 1.5 g in 1 VIAL (0641-6116-01)
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611901

NDC 90641-6119
NDC 100641-6119-01
NDC Item00641611901
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641611910

NDC 90641-6119
NDC 100641-6119-10
NDC Item00641611910
Packaging10 VIAL in 1 CARTON (0641-6119-10) / 1.5 g in 1 VIAL (0641-6119-01)
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641612201

NDC 90641-6122
NDC 100641-6122-01
NDC Item00641612201
Packaging4 mL in 1 VIAL
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00641612210

NDC 90641-6122
NDC 100641-6122-10
NDC Item00641612210
Packaging10 VIAL in 1 CARTON (0641-6122-10) / 4 mL in 1 VIAL (0641-6122-01)
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00781303270

NDC 90781-3032
NDC 100781-3032-70
NDC Item00781303270
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 00781303295

NDC 90781-3032
NDC 100781-3032-95
NDC Item00781303295
Packaging10 VIAL in 1 CARTON (0781-3032-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-3032-70)
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 25021014220

NDC 925021-142
NDC 1025021-142-20
NDC Item25021014220
Packaging10 VIAL in 1 CARTON (25021-142-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065406
FDA SPL set id612973
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-06-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 25021-142

NDC Item 25021018620

NDC 925021-186
NDC 1025021-186-20
NDC Item25021018620
Packaging10 VIAL in 1 CARTON (25021-186-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090579
FDA SPL set id549185
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-03-31
Marketing effective time low2017-08-15
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 25021-186

NDC Item 44567021010

NDC 944567-210
NDC 1044567-210-10
NDC Item44567021010
Packaging10 VIAL in 1 CARTON (44567-210-10) / 10 mL in 1 VIAL
ANDAANDA065176
FDA SPL set id803837
LabelerWG Critical Care, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 44567-210

NDC Item 55150011601

NDC 955150-116
NDC 1055150-116-01
NDC Item55150011601
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011610

NDC 955150-116
NDC 1055150-116-10
NDC Item55150011610
Packaging10 VIAL in 1 CARTON (55150-116-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011620

NDC 955150-116
NDC 1055150-116-20
NDC Item55150011620
Packaging10 VIAL in 1 CARTON (55150-116-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150017899

NDC 955150-178
NDC 1055150-178-99
NDC Item55150017899
Packaging10 BOTTLE in 1 BOX (55150-178-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE
ANDAANDA090340
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-09-13
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-178

NDC Item 63323036820

NDC 963323-368
NDC 1063323-368-20
NDC Item63323036820
Packaging10 VIAL in 1 CARTON (63323-368-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065222
FDA SPL set id460623
LabelerFresenius Kabi USA, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2016-05-05
Marketing effective time low2005-11-29
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 63323-368

NDC Item 66794020602

NDC 966794-206
NDC 1066794-206-02
NDC Item66794020602
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794020641

NDC 966794-206
NDC 1066794-206-41
NDC Item66794020641
Packaging10 VIAL in 1 CARTON (66794-206-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-206-02)
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794024102

NDC 966794-241
NDC 1066794-241-02
NDC Item66794024102
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 66794024141

NDC 966794-241
NDC 1066794-241-41
NDC Item66794024141
Packaging10 VIAL in 1 CARTON (66794-241-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-241-02)
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 67457034810

NDC 967457-348
NDC 1067457-348-10
NDC Item67457034810
Packaging10 VIAL in 1 CARTON (67457-348-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67457034815

NDC 967457-348
NDC 1067457-348-15
NDC Item67457034815
Packaging1 VIAL in 1 CARTON (67457-348-15) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67850013000

NDC 967850-130
NDC 1067850-130-00
NDC Item67850013000
Packaging1 in 1 VIAL, GLASS
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 67850013010

NDC 967850-130
NDC 1067850-130-10
NDC Item67850013010
Packaging10 VIAL, GLASS in 1 CARTON (67850-130-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (67850-130-00)
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 70594008101

NDC 970594-081
NDC 1070594-081-01
NDC Item70594008101
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 70594008102

NDC 970594-081
NDC 1070594-081-02
NDC Item70594008102
Packaging10 VIAL in 1 CARTON (70594-081-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-081-01)
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 71288000520

NDC 971288-005
NDC 1071288-005-20
NDC Item71288000520
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-005-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-005-21)
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288000521

NDC 971288-005
NDC 1071288-005-21
NDC Item71288000521
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288003120

NDC 971288-031
NDC 1071288-031-20
NDC Item71288003120
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003121

NDC 971288-031
NDC 1071288-031-21
NDC Item71288003121
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-21) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-20)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003191

NDC 971288-031
NDC 1071288-031-91
NDC Item71288003191
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003192

NDC 971288-031
NDC 1071288-031-92
NDC Item71288003192
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-92) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-91)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 72485041601

NDC 972485-416
NDC 1072485-416-01
NDC Item72485041601
Packaging1 in 1 VIAL
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72485041610

NDC 972485-416
NDC 1072485-416-10
NDC Item72485041610
Packaging10 VIAL in 1 CARTON (72485-416-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72485-416-01)
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72572002101

NDC 972572-021
NDC 1072572-021-01
NDC Item72572002101
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72572002110

NDC 972572-021
NDC 1072572-021-10
NDC Item72572002110
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72572-021-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72572-021-01)
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72603022001

NDC 972603-220
NDC 1072603-220-01
NDC Item72603022001
Packaging1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusactive
Related queriesProperties for NDC 9 72603-220

NDC Item 72603022010

NDC 972603-220
NDC 1072603-220-10
NDC Item72603022010
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72603-220-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 72603-220

NDC Item 82449051301

NDC 982449-513
NDC 1082449-513-01
NDC Item82449051301
Packaging1 VIAL in 1 CARTON (82449-513-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 82449051302

NDC 982449-513
NDC 1082449-513-02
NDC Item82449051302
Packaging10 VIAL in 1 CARTON (82449-513-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 00409268901

NDC 90409-2689
NDC 100409-2689-01
NDC Item00409268901
Packaging10 VIAL in 1 TRAY (0409-2689-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0409-2689-21)
ANDAANDA065310
FDA SPL set id806154
LabelerHospira, Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-07-25
Marketing statusACTIVE
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268921

NDC 90409-2689
NDC 100409-2689-21
NDC Item00409268921
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268949

NDC 90409-2689
NDC 100409-2689-49
NDC Item00409268949
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00641611601

NDC 90641-6116
NDC 100641-6116-01
NDC Item00641611601
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611610

NDC 90641-6116
NDC 100641-6116-10
NDC Item00641611610
Packaging10 VIAL in 1 CARTON (0641-6116-10) / 1.5 g in 1 VIAL (0641-6116-01)
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611901

NDC 90641-6119
NDC 100641-6119-01
NDC Item00641611901
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641611910

NDC 90641-6119
NDC 100641-6119-10
NDC Item00641611910
Packaging10 VIAL in 1 CARTON (0641-6119-10) / 1.5 g in 1 VIAL (0641-6119-01)
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641612201

NDC 90641-6122
NDC 100641-6122-01
NDC Item00641612201
Packaging4 mL in 1 VIAL
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00641612210

NDC 90641-6122
NDC 100641-6122-10
NDC Item00641612210
Packaging10 VIAL in 1 CARTON (0641-6122-10) / 4 mL in 1 VIAL (0641-6122-01)
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00781303270

NDC 90781-3032
NDC 100781-3032-70
NDC Item00781303270
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 00781303295

NDC 90781-3032
NDC 100781-3032-95
NDC Item00781303295
Packaging10 VIAL in 1 CARTON (0781-3032-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-3032-70)
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 25021014220

NDC 925021-142
NDC 1025021-142-20
NDC Item25021014220
Packaging10 VIAL in 1 CARTON (25021-142-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065406
FDA SPL set id612973
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-06-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 25021-142

NDC Item 25021018620

NDC 925021-186
NDC 1025021-186-20
NDC Item25021018620
Packaging10 VIAL in 1 CARTON (25021-186-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090579
FDA SPL set id549185
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-03-31
Marketing effective time low2017-08-15
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 25021-186

NDC Item 44567021010

NDC 944567-210
NDC 1044567-210-10
NDC Item44567021010
Packaging10 VIAL in 1 CARTON (44567-210-10) / 10 mL in 1 VIAL
ANDAANDA065176
FDA SPL set id803837
LabelerWG Critical Care, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 44567-210

NDC Item 55150011601

NDC 955150-116
NDC 1055150-116-01
NDC Item55150011601
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011610

NDC 955150-116
NDC 1055150-116-10
NDC Item55150011610
Packaging10 VIAL in 1 CARTON (55150-116-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011620

NDC 955150-116
NDC 1055150-116-20
NDC Item55150011620
Packaging10 VIAL in 1 CARTON (55150-116-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150017899

NDC 955150-178
NDC 1055150-178-99
NDC Item55150017899
Packaging10 BOTTLE in 1 BOX (55150-178-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE
ANDAANDA090340
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-09-13
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-178

NDC Item 63323036820

NDC 963323-368
NDC 1063323-368-20
NDC Item63323036820
Packaging10 VIAL in 1 CARTON (63323-368-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065222
FDA SPL set id460623
LabelerFresenius Kabi USA, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2016-05-05
Marketing effective time low2005-11-29
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 63323-368

NDC Item 66794020602

NDC 966794-206
NDC 1066794-206-02
NDC Item66794020602
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794020641

NDC 966794-206
NDC 1066794-206-41
NDC Item66794020641
Packaging10 VIAL in 1 CARTON (66794-206-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-206-02)
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794024102

NDC 966794-241
NDC 1066794-241-02
NDC Item66794024102
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 66794024141

NDC 966794-241
NDC 1066794-241-41
NDC Item66794024141
Packaging10 VIAL in 1 CARTON (66794-241-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-241-02)
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 67457034810

NDC 967457-348
NDC 1067457-348-10
NDC Item67457034810
Packaging10 VIAL in 1 CARTON (67457-348-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67457034815

NDC 967457-348
NDC 1067457-348-15
NDC Item67457034815
Packaging1 VIAL in 1 CARTON (67457-348-15) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67850013000

NDC 967850-130
NDC 1067850-130-00
NDC Item67850013000
Packaging1 in 1 VIAL, GLASS
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 67850013010

NDC 967850-130
NDC 1067850-130-10
NDC Item67850013010
Packaging10 VIAL, GLASS in 1 CARTON (67850-130-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (67850-130-00)
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 70594008101

NDC 970594-081
NDC 1070594-081-01
NDC Item70594008101
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 70594008102

NDC 970594-081
NDC 1070594-081-02
NDC Item70594008102
Packaging10 VIAL in 1 CARTON (70594-081-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-081-01)
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 71288000520

NDC 971288-005
NDC 1071288-005-20
NDC Item71288000520
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-005-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-005-21)
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288000521

NDC 971288-005
NDC 1071288-005-21
NDC Item71288000521
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288003120

NDC 971288-031
NDC 1071288-031-20
NDC Item71288003120
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003121

NDC 971288-031
NDC 1071288-031-21
NDC Item71288003121
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-21) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-20)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003191

NDC 971288-031
NDC 1071288-031-91
NDC Item71288003191
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003192

NDC 971288-031
NDC 1071288-031-92
NDC Item71288003192
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-92) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-91)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 72485041601

NDC 972485-416
NDC 1072485-416-01
NDC Item72485041601
Packaging1 in 1 VIAL
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72485041610

NDC 972485-416
NDC 1072485-416-10
NDC Item72485041610
Packaging10 VIAL in 1 CARTON (72485-416-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72485-416-01)
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72572002101

NDC 972572-021
NDC 1072572-021-01
NDC Item72572002101
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72572002110

NDC 972572-021
NDC 1072572-021-10
NDC Item72572002110
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72572-021-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72572-021-01)
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72603022001

NDC 972603-220
NDC 1072603-220-01
NDC Item72603022001
Packaging1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusactive
Related queriesProperties for NDC 9 72603-220

NDC Item 72603022010

NDC 972603-220
NDC 1072603-220-10
NDC Item72603022010
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72603-220-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 72603-220

NDC Item 82449051301

NDC 982449-513
NDC 1082449-513-01
NDC Item82449051301
Packaging1 VIAL in 1 CARTON (82449-513-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 82449051302

NDC 982449-513
NDC 1082449-513-02
NDC Item82449051302
Packaging10 VIAL in 1 CARTON (82449-513-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 00409268901

NDC 90409-2689
NDC 100409-2689-01
NDC Item00409268901
Packaging10 VIAL in 1 TRAY (0409-2689-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0409-2689-21)
ANDAANDA065310
FDA SPL set id806154
LabelerHospira, Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-07-25
Marketing statusACTIVE
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268921

NDC 90409-2689
NDC 100409-2689-21
NDC Item00409268921
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268949

NDC 90409-2689
NDC 100409-2689-49
NDC Item00409268949
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00641611601

NDC 90641-6116
NDC 100641-6116-01
NDC Item00641611601
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611610

NDC 90641-6116
NDC 100641-6116-10
NDC Item00641611610
Packaging10 VIAL in 1 CARTON (0641-6116-10) / 1.5 g in 1 VIAL (0641-6116-01)
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611901

NDC 90641-6119
NDC 100641-6119-01
NDC Item00641611901
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641611910

NDC 90641-6119
NDC 100641-6119-10
NDC Item00641611910
Packaging10 VIAL in 1 CARTON (0641-6119-10) / 1.5 g in 1 VIAL (0641-6119-01)
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641612201

NDC 90641-6122
NDC 100641-6122-01
NDC Item00641612201
Packaging4 mL in 1 VIAL
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00641612210

NDC 90641-6122
NDC 100641-6122-10
NDC Item00641612210
Packaging10 VIAL in 1 CARTON (0641-6122-10) / 4 mL in 1 VIAL (0641-6122-01)
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00781303270

NDC 90781-3032
NDC 100781-3032-70
NDC Item00781303270
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 00781303295

NDC 90781-3032
NDC 100781-3032-95
NDC Item00781303295
Packaging10 VIAL in 1 CARTON (0781-3032-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-3032-70)
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 25021014220

NDC 925021-142
NDC 1025021-142-20
NDC Item25021014220
Packaging10 VIAL in 1 CARTON (25021-142-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065406
FDA SPL set id612973
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-06-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 25021-142

NDC Item 25021018620

NDC 925021-186
NDC 1025021-186-20
NDC Item25021018620
Packaging10 VIAL in 1 CARTON (25021-186-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090579
FDA SPL set id549185
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-03-31
Marketing effective time low2017-08-15
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 25021-186

NDC Item 44567021010

NDC 944567-210
NDC 1044567-210-10
NDC Item44567021010
Packaging10 VIAL in 1 CARTON (44567-210-10) / 10 mL in 1 VIAL
ANDAANDA065176
FDA SPL set id803837
LabelerWG Critical Care, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 44567-210

NDC Item 55150011601

NDC 955150-116
NDC 1055150-116-01
NDC Item55150011601
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011610

NDC 955150-116
NDC 1055150-116-10
NDC Item55150011610
Packaging10 VIAL in 1 CARTON (55150-116-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011620

NDC 955150-116
NDC 1055150-116-20
NDC Item55150011620
Packaging10 VIAL in 1 CARTON (55150-116-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150017899

NDC 955150-178
NDC 1055150-178-99
NDC Item55150017899
Packaging10 BOTTLE in 1 BOX (55150-178-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE
ANDAANDA090340
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-09-13
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-178

NDC Item 63323036820

NDC 963323-368
NDC 1063323-368-20
NDC Item63323036820
Packaging10 VIAL in 1 CARTON (63323-368-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065222
FDA SPL set id460623
LabelerFresenius Kabi USA, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2016-05-05
Marketing effective time low2005-11-29
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 63323-368

NDC Item 66794020602

NDC 966794-206
NDC 1066794-206-02
NDC Item66794020602
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794020641

NDC 966794-206
NDC 1066794-206-41
NDC Item66794020641
Packaging10 VIAL in 1 CARTON (66794-206-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-206-02)
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794024102

NDC 966794-241
NDC 1066794-241-02
NDC Item66794024102
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 66794024141

NDC 966794-241
NDC 1066794-241-41
NDC Item66794024141
Packaging10 VIAL in 1 CARTON (66794-241-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-241-02)
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 67457034810

NDC 967457-348
NDC 1067457-348-10
NDC Item67457034810
Packaging10 VIAL in 1 CARTON (67457-348-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67457034815

NDC 967457-348
NDC 1067457-348-15
NDC Item67457034815
Packaging1 VIAL in 1 CARTON (67457-348-15) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67850013000

NDC 967850-130
NDC 1067850-130-00
NDC Item67850013000
Packaging1 in 1 VIAL, GLASS
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 67850013010

NDC 967850-130
NDC 1067850-130-10
NDC Item67850013010
Packaging10 VIAL, GLASS in 1 CARTON (67850-130-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (67850-130-00)
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 70594008101

NDC 970594-081
NDC 1070594-081-01
NDC Item70594008101
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 70594008102

NDC 970594-081
NDC 1070594-081-02
NDC Item70594008102
Packaging10 VIAL in 1 CARTON (70594-081-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-081-01)
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 71288000520

NDC 971288-005
NDC 1071288-005-20
NDC Item71288000520
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-005-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-005-21)
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288000521

NDC 971288-005
NDC 1071288-005-21
NDC Item71288000521
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288003120

NDC 971288-031
NDC 1071288-031-20
NDC Item71288003120
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003121

NDC 971288-031
NDC 1071288-031-21
NDC Item71288003121
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-21) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-20)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003191

NDC 971288-031
NDC 1071288-031-91
NDC Item71288003191
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003192

NDC 971288-031
NDC 1071288-031-92
NDC Item71288003192
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-92) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-91)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 72485041601

NDC 972485-416
NDC 1072485-416-01
NDC Item72485041601
Packaging1 in 1 VIAL
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72485041610

NDC 972485-416
NDC 1072485-416-10
NDC Item72485041610
Packaging10 VIAL in 1 CARTON (72485-416-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72485-416-01)
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72572002101

NDC 972572-021
NDC 1072572-021-01
NDC Item72572002101
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72572002110

NDC 972572-021
NDC 1072572-021-10
NDC Item72572002110
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72572-021-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72572-021-01)
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72603022001

NDC 972603-220
NDC 1072603-220-01
NDC Item72603022001
Packaging1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusactive
Related queriesProperties for NDC 9 72603-220

NDC Item 72603022010

NDC 972603-220
NDC 1072603-220-10
NDC Item72603022010
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72603-220-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 72603-220

NDC Item 82449051301

NDC 982449-513
NDC 1082449-513-01
NDC Item82449051301
Packaging1 VIAL in 1 CARTON (82449-513-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 82449051302

NDC 982449-513
NDC 1082449-513-02
NDC Item82449051302
Packaging10 VIAL in 1 CARTON (82449-513-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 00409268901

NDC 90409-2689
NDC 100409-2689-01
NDC Item00409268901
Packaging10 VIAL in 1 TRAY (0409-2689-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0409-2689-21)
ANDAANDA065310
FDA SPL set id806154
LabelerHospira, Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-07-25
Marketing statusACTIVE
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268921

NDC 90409-2689
NDC 100409-2689-21
NDC Item00409268921
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268949

NDC 90409-2689
NDC 100409-2689-49
NDC Item00409268949
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00641611601

NDC 90641-6116
NDC 100641-6116-01
NDC Item00641611601
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611610

NDC 90641-6116
NDC 100641-6116-10
NDC Item00641611610
Packaging10 VIAL in 1 CARTON (0641-6116-10) / 1.5 g in 1 VIAL (0641-6116-01)
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611901

NDC 90641-6119
NDC 100641-6119-01
NDC Item00641611901
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641611910

NDC 90641-6119
NDC 100641-6119-10
NDC Item00641611910
Packaging10 VIAL in 1 CARTON (0641-6119-10) / 1.5 g in 1 VIAL (0641-6119-01)
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641612201

NDC 90641-6122
NDC 100641-6122-01
NDC Item00641612201
Packaging4 mL in 1 VIAL
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00641612210

NDC 90641-6122
NDC 100641-6122-10
NDC Item00641612210
Packaging10 VIAL in 1 CARTON (0641-6122-10) / 4 mL in 1 VIAL (0641-6122-01)
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00781303270

NDC 90781-3032
NDC 100781-3032-70
NDC Item00781303270
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 00781303295

NDC 90781-3032
NDC 100781-3032-95
NDC Item00781303295
Packaging10 VIAL in 1 CARTON (0781-3032-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-3032-70)
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 25021014220

NDC 925021-142
NDC 1025021-142-20
NDC Item25021014220
Packaging10 VIAL in 1 CARTON (25021-142-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065406
FDA SPL set id612973
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-06-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 25021-142

NDC Item 25021018620

NDC 925021-186
NDC 1025021-186-20
NDC Item25021018620
Packaging10 VIAL in 1 CARTON (25021-186-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090579
FDA SPL set id549185
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-03-31
Marketing effective time low2017-08-15
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 25021-186

NDC Item 44567021010

NDC 944567-210
NDC 1044567-210-10
NDC Item44567021010
Packaging10 VIAL in 1 CARTON (44567-210-10) / 10 mL in 1 VIAL
ANDAANDA065176
FDA SPL set id803837
LabelerWG Critical Care, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 44567-210

NDC Item 55150011601

NDC 955150-116
NDC 1055150-116-01
NDC Item55150011601
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011610

NDC 955150-116
NDC 1055150-116-10
NDC Item55150011610
Packaging10 VIAL in 1 CARTON (55150-116-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011620

NDC 955150-116
NDC 1055150-116-20
NDC Item55150011620
Packaging10 VIAL in 1 CARTON (55150-116-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150017899

NDC 955150-178
NDC 1055150-178-99
NDC Item55150017899
Packaging10 BOTTLE in 1 BOX (55150-178-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE
ANDAANDA090340
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-09-13
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-178

NDC Item 63323036820

NDC 963323-368
NDC 1063323-368-20
NDC Item63323036820
Packaging10 VIAL in 1 CARTON (63323-368-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065222
FDA SPL set id460623
LabelerFresenius Kabi USA, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2016-05-05
Marketing effective time low2005-11-29
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 63323-368

NDC Item 66794020602

NDC 966794-206
NDC 1066794-206-02
NDC Item66794020602
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794020641

NDC 966794-206
NDC 1066794-206-41
NDC Item66794020641
Packaging10 VIAL in 1 CARTON (66794-206-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-206-02)
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794024102

NDC 966794-241
NDC 1066794-241-02
NDC Item66794024102
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 66794024141

NDC 966794-241
NDC 1066794-241-41
NDC Item66794024141
Packaging10 VIAL in 1 CARTON (66794-241-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-241-02)
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 67457034810

NDC 967457-348
NDC 1067457-348-10
NDC Item67457034810
Packaging10 VIAL in 1 CARTON (67457-348-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67457034815

NDC 967457-348
NDC 1067457-348-15
NDC Item67457034815
Packaging1 VIAL in 1 CARTON (67457-348-15) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67850013000

NDC 967850-130
NDC 1067850-130-00
NDC Item67850013000
Packaging1 in 1 VIAL, GLASS
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 67850013010

NDC 967850-130
NDC 1067850-130-10
NDC Item67850013010
Packaging10 VIAL, GLASS in 1 CARTON (67850-130-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (67850-130-00)
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 70594008101

NDC 970594-081
NDC 1070594-081-01
NDC Item70594008101
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 70594008102

NDC 970594-081
NDC 1070594-081-02
NDC Item70594008102
Packaging10 VIAL in 1 CARTON (70594-081-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-081-01)
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 71288000520

NDC 971288-005
NDC 1071288-005-20
NDC Item71288000520
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-005-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-005-21)
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288000521

NDC 971288-005
NDC 1071288-005-21
NDC Item71288000521
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288003120

NDC 971288-031
NDC 1071288-031-20
NDC Item71288003120
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003121

NDC 971288-031
NDC 1071288-031-21
NDC Item71288003121
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-21) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-20)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003191

NDC 971288-031
NDC 1071288-031-91
NDC Item71288003191
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003192

NDC 971288-031
NDC 1071288-031-92
NDC Item71288003192
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-92) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-91)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 72485041601

NDC 972485-416
NDC 1072485-416-01
NDC Item72485041601
Packaging1 in 1 VIAL
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72485041610

NDC 972485-416
NDC 1072485-416-10
NDC Item72485041610
Packaging10 VIAL in 1 CARTON (72485-416-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72485-416-01)
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72572002101

NDC 972572-021
NDC 1072572-021-01
NDC Item72572002101
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72572002110

NDC 972572-021
NDC 1072572-021-10
NDC Item72572002110
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72572-021-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72572-021-01)
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72603022001

NDC 972603-220
NDC 1072603-220-01
NDC Item72603022001
Packaging1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusactive
Related queriesProperties for NDC 9 72603-220

NDC Item 72603022010

NDC 972603-220
NDC 1072603-220-10
NDC Item72603022010
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72603-220-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 72603-220

NDC Item 82449051301

NDC 982449-513
NDC 1082449-513-01
NDC Item82449051301
Packaging1 VIAL in 1 CARTON (82449-513-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 82449051302

NDC 982449-513
NDC 1082449-513-02
NDC Item82449051302
Packaging10 VIAL in 1 CARTON (82449-513-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 00409268901

NDC 90409-2689
NDC 100409-2689-01
NDC Item00409268901
Packaging10 VIAL in 1 TRAY (0409-2689-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0409-2689-21)
ANDAANDA065310
FDA SPL set id806154
LabelerHospira, Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-07-25
Marketing statusACTIVE
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268921

NDC 90409-2689
NDC 100409-2689-21
NDC Item00409268921
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268949

NDC 90409-2689
NDC 100409-2689-49
NDC Item00409268949
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00641611601

NDC 90641-6116
NDC 100641-6116-01
NDC Item00641611601
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611610

NDC 90641-6116
NDC 100641-6116-10
NDC Item00641611610
Packaging10 VIAL in 1 CARTON (0641-6116-10) / 1.5 g in 1 VIAL (0641-6116-01)
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611901

NDC 90641-6119
NDC 100641-6119-01
NDC Item00641611901
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641611910

NDC 90641-6119
NDC 100641-6119-10
NDC Item00641611910
Packaging10 VIAL in 1 CARTON (0641-6119-10) / 1.5 g in 1 VIAL (0641-6119-01)
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641612201

NDC 90641-6122
NDC 100641-6122-01
NDC Item00641612201
Packaging4 mL in 1 VIAL
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00641612210

NDC 90641-6122
NDC 100641-6122-10
NDC Item00641612210
Packaging10 VIAL in 1 CARTON (0641-6122-10) / 4 mL in 1 VIAL (0641-6122-01)
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00781303270

NDC 90781-3032
NDC 100781-3032-70
NDC Item00781303270
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 00781303295

NDC 90781-3032
NDC 100781-3032-95
NDC Item00781303295
Packaging10 VIAL in 1 CARTON (0781-3032-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-3032-70)
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 25021014220

NDC 925021-142
NDC 1025021-142-20
NDC Item25021014220
Packaging10 VIAL in 1 CARTON (25021-142-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065406
FDA SPL set id612973
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-06-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 25021-142

NDC Item 25021018620

NDC 925021-186
NDC 1025021-186-20
NDC Item25021018620
Packaging10 VIAL in 1 CARTON (25021-186-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090579
FDA SPL set id549185
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-03-31
Marketing effective time low2017-08-15
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 25021-186

NDC Item 44567021010

NDC 944567-210
NDC 1044567-210-10
NDC Item44567021010
Packaging10 VIAL in 1 CARTON (44567-210-10) / 10 mL in 1 VIAL
ANDAANDA065176
FDA SPL set id803837
LabelerWG Critical Care, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 44567-210

NDC Item 55150011601

NDC 955150-116
NDC 1055150-116-01
NDC Item55150011601
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011610

NDC 955150-116
NDC 1055150-116-10
NDC Item55150011610
Packaging10 VIAL in 1 CARTON (55150-116-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011620

NDC 955150-116
NDC 1055150-116-20
NDC Item55150011620
Packaging10 VIAL in 1 CARTON (55150-116-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150017899

NDC 955150-178
NDC 1055150-178-99
NDC Item55150017899
Packaging10 BOTTLE in 1 BOX (55150-178-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE
ANDAANDA090340
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-09-13
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-178

NDC Item 63323036820

NDC 963323-368
NDC 1063323-368-20
NDC Item63323036820
Packaging10 VIAL in 1 CARTON (63323-368-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065222
FDA SPL set id460623
LabelerFresenius Kabi USA, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2016-05-05
Marketing effective time low2005-11-29
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 63323-368

NDC Item 66794020602

NDC 966794-206
NDC 1066794-206-02
NDC Item66794020602
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794020641

NDC 966794-206
NDC 1066794-206-41
NDC Item66794020641
Packaging10 VIAL in 1 CARTON (66794-206-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-206-02)
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794024102

NDC 966794-241
NDC 1066794-241-02
NDC Item66794024102
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 66794024141

NDC 966794-241
NDC 1066794-241-41
NDC Item66794024141
Packaging10 VIAL in 1 CARTON (66794-241-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-241-02)
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 67457034810

NDC 967457-348
NDC 1067457-348-10
NDC Item67457034810
Packaging10 VIAL in 1 CARTON (67457-348-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67457034815

NDC 967457-348
NDC 1067457-348-15
NDC Item67457034815
Packaging1 VIAL in 1 CARTON (67457-348-15) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67850013000

NDC 967850-130
NDC 1067850-130-00
NDC Item67850013000
Packaging1 in 1 VIAL, GLASS
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 67850013010

NDC 967850-130
NDC 1067850-130-10
NDC Item67850013010
Packaging10 VIAL, GLASS in 1 CARTON (67850-130-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (67850-130-00)
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 70594008101

NDC 970594-081
NDC 1070594-081-01
NDC Item70594008101
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 70594008102

NDC 970594-081
NDC 1070594-081-02
NDC Item70594008102
Packaging10 VIAL in 1 CARTON (70594-081-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-081-01)
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 71288000520

NDC 971288-005
NDC 1071288-005-20
NDC Item71288000520
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-005-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-005-21)
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288000521

NDC 971288-005
NDC 1071288-005-21
NDC Item71288000521
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288003120

NDC 971288-031
NDC 1071288-031-20
NDC Item71288003120
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003121

NDC 971288-031
NDC 1071288-031-21
NDC Item71288003121
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-21) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-20)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003191

NDC 971288-031
NDC 1071288-031-91
NDC Item71288003191
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003192

NDC 971288-031
NDC 1071288-031-92
NDC Item71288003192
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-92) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-91)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 72485041601

NDC 972485-416
NDC 1072485-416-01
NDC Item72485041601
Packaging1 in 1 VIAL
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72485041610

NDC 972485-416
NDC 1072485-416-10
NDC Item72485041610
Packaging10 VIAL in 1 CARTON (72485-416-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72485-416-01)
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72572002101

NDC 972572-021
NDC 1072572-021-01
NDC Item72572002101
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72572002110

NDC 972572-021
NDC 1072572-021-10
NDC Item72572002110
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72572-021-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72572-021-01)
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72603022001

NDC 972603-220
NDC 1072603-220-01
NDC Item72603022001
Packaging1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusactive
Related queriesProperties for NDC 9 72603-220

NDC Item 72603022010

NDC 972603-220
NDC 1072603-220-10
NDC Item72603022010
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72603-220-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 72603-220

NDC Item 82449051301

NDC 982449-513
NDC 1082449-513-01
NDC Item82449051301
Packaging1 VIAL in 1 CARTON (82449-513-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 82449051302

NDC 982449-513
NDC 1082449-513-02
NDC Item82449051302
Packaging10 VIAL in 1 CARTON (82449-513-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 00409268901

NDC 90409-2689
NDC 100409-2689-01
NDC Item00409268901
Packaging10 VIAL in 1 TRAY (0409-2689-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0409-2689-21)
ANDAANDA065310
FDA SPL set id806154
LabelerHospira, Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-07-25
Marketing statusACTIVE
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268921

NDC 90409-2689
NDC 100409-2689-21
NDC Item00409268921
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268949

NDC 90409-2689
NDC 100409-2689-49
NDC Item00409268949
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00641611601

NDC 90641-6116
NDC 100641-6116-01
NDC Item00641611601
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611610

NDC 90641-6116
NDC 100641-6116-10
NDC Item00641611610
Packaging10 VIAL in 1 CARTON (0641-6116-10) / 1.5 g in 1 VIAL (0641-6116-01)
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611901

NDC 90641-6119
NDC 100641-6119-01
NDC Item00641611901
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641611910

NDC 90641-6119
NDC 100641-6119-10
NDC Item00641611910
Packaging10 VIAL in 1 CARTON (0641-6119-10) / 1.5 g in 1 VIAL (0641-6119-01)
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641612201

NDC 90641-6122
NDC 100641-6122-01
NDC Item00641612201
Packaging4 mL in 1 VIAL
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00641612210

NDC 90641-6122
NDC 100641-6122-10
NDC Item00641612210
Packaging10 VIAL in 1 CARTON (0641-6122-10) / 4 mL in 1 VIAL (0641-6122-01)
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00781303270

NDC 90781-3032
NDC 100781-3032-70
NDC Item00781303270
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 00781303295

NDC 90781-3032
NDC 100781-3032-95
NDC Item00781303295
Packaging10 VIAL in 1 CARTON (0781-3032-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-3032-70)
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 25021014220

NDC 925021-142
NDC 1025021-142-20
NDC Item25021014220
Packaging10 VIAL in 1 CARTON (25021-142-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065406
FDA SPL set id612973
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-06-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 25021-142

NDC Item 25021018620

NDC 925021-186
NDC 1025021-186-20
NDC Item25021018620
Packaging10 VIAL in 1 CARTON (25021-186-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090579
FDA SPL set id549185
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-03-31
Marketing effective time low2017-08-15
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 25021-186

NDC Item 44567021010

NDC 944567-210
NDC 1044567-210-10
NDC Item44567021010
Packaging10 VIAL in 1 CARTON (44567-210-10) / 10 mL in 1 VIAL
ANDAANDA065176
FDA SPL set id803837
LabelerWG Critical Care, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 44567-210

NDC Item 55150011601

NDC 955150-116
NDC 1055150-116-01
NDC Item55150011601
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011610

NDC 955150-116
NDC 1055150-116-10
NDC Item55150011610
Packaging10 VIAL in 1 CARTON (55150-116-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011620

NDC 955150-116
NDC 1055150-116-20
NDC Item55150011620
Packaging10 VIAL in 1 CARTON (55150-116-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150017899

NDC 955150-178
NDC 1055150-178-99
NDC Item55150017899
Packaging10 BOTTLE in 1 BOX (55150-178-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE
ANDAANDA090340
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-09-13
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-178

NDC Item 63323036820

NDC 963323-368
NDC 1063323-368-20
NDC Item63323036820
Packaging10 VIAL in 1 CARTON (63323-368-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065222
FDA SPL set id460623
LabelerFresenius Kabi USA, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2016-05-05
Marketing effective time low2005-11-29
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 63323-368

NDC Item 66794020602

NDC 966794-206
NDC 1066794-206-02
NDC Item66794020602
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794020641

NDC 966794-206
NDC 1066794-206-41
NDC Item66794020641
Packaging10 VIAL in 1 CARTON (66794-206-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-206-02)
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794024102

NDC 966794-241
NDC 1066794-241-02
NDC Item66794024102
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 66794024141

NDC 966794-241
NDC 1066794-241-41
NDC Item66794024141
Packaging10 VIAL in 1 CARTON (66794-241-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-241-02)
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 67457034810

NDC 967457-348
NDC 1067457-348-10
NDC Item67457034810
Packaging10 VIAL in 1 CARTON (67457-348-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67457034815

NDC 967457-348
NDC 1067457-348-15
NDC Item67457034815
Packaging1 VIAL in 1 CARTON (67457-348-15) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67850013000

NDC 967850-130
NDC 1067850-130-00
NDC Item67850013000
Packaging1 in 1 VIAL, GLASS
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 67850013010

NDC 967850-130
NDC 1067850-130-10
NDC Item67850013010
Packaging10 VIAL, GLASS in 1 CARTON (67850-130-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (67850-130-00)
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 70594008101

NDC 970594-081
NDC 1070594-081-01
NDC Item70594008101
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 70594008102

NDC 970594-081
NDC 1070594-081-02
NDC Item70594008102
Packaging10 VIAL in 1 CARTON (70594-081-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-081-01)
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 71288000520

NDC 971288-005
NDC 1071288-005-20
NDC Item71288000520
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-005-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-005-21)
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288000521

NDC 971288-005
NDC 1071288-005-21
NDC Item71288000521
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288003120

NDC 971288-031
NDC 1071288-031-20
NDC Item71288003120
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003121

NDC 971288-031
NDC 1071288-031-21
NDC Item71288003121
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-21) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-20)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003191

NDC 971288-031
NDC 1071288-031-91
NDC Item71288003191
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003192

NDC 971288-031
NDC 1071288-031-92
NDC Item71288003192
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-92) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-91)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 72485041601

NDC 972485-416
NDC 1072485-416-01
NDC Item72485041601
Packaging1 in 1 VIAL
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72485041610

NDC 972485-416
NDC 1072485-416-10
NDC Item72485041610
Packaging10 VIAL in 1 CARTON (72485-416-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72485-416-01)
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72572002101

NDC 972572-021
NDC 1072572-021-01
NDC Item72572002101
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72572002110

NDC 972572-021
NDC 1072572-021-10
NDC Item72572002110
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72572-021-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72572-021-01)
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72603022001

NDC 972603-220
NDC 1072603-220-01
NDC Item72603022001
Packaging1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusactive
Related queriesProperties for NDC 9 72603-220

NDC Item 72603022010

NDC 972603-220
NDC 1072603-220-10
NDC Item72603022010
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72603-220-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 72603-220

NDC Item 82449051301

NDC 982449-513
NDC 1082449-513-01
NDC Item82449051301
Packaging1 VIAL in 1 CARTON (82449-513-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 82449051302

NDC 982449-513
NDC 1082449-513-02
NDC Item82449051302
Packaging10 VIAL in 1 CARTON (82449-513-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 00409268901

NDC 90409-2689
NDC 100409-2689-01
NDC Item00409268901
Packaging10 VIAL in 1 TRAY (0409-2689-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0409-2689-21)
ANDAANDA065310
FDA SPL set id806154
LabelerHospira, Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-07-25
Marketing statusACTIVE
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268921

NDC 90409-2689
NDC 100409-2689-21
NDC Item00409268921
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268949

NDC 90409-2689
NDC 100409-2689-49
NDC Item00409268949
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00641611601

NDC 90641-6116
NDC 100641-6116-01
NDC Item00641611601
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611610

NDC 90641-6116
NDC 100641-6116-10
NDC Item00641611610
Packaging10 VIAL in 1 CARTON (0641-6116-10) / 1.5 g in 1 VIAL (0641-6116-01)
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611901

NDC 90641-6119
NDC 100641-6119-01
NDC Item00641611901
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641611910

NDC 90641-6119
NDC 100641-6119-10
NDC Item00641611910
Packaging10 VIAL in 1 CARTON (0641-6119-10) / 1.5 g in 1 VIAL (0641-6119-01)
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641612201

NDC 90641-6122
NDC 100641-6122-01
NDC Item00641612201
Packaging4 mL in 1 VIAL
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00641612210

NDC 90641-6122
NDC 100641-6122-10
NDC Item00641612210
Packaging10 VIAL in 1 CARTON (0641-6122-10) / 4 mL in 1 VIAL (0641-6122-01)
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00781303270

NDC 90781-3032
NDC 100781-3032-70
NDC Item00781303270
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 00781303295

NDC 90781-3032
NDC 100781-3032-95
NDC Item00781303295
Packaging10 VIAL in 1 CARTON (0781-3032-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-3032-70)
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 25021014220

NDC 925021-142
NDC 1025021-142-20
NDC Item25021014220
Packaging10 VIAL in 1 CARTON (25021-142-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065406
FDA SPL set id612973
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-06-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 25021-142

NDC Item 25021018620

NDC 925021-186
NDC 1025021-186-20
NDC Item25021018620
Packaging10 VIAL in 1 CARTON (25021-186-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090579
FDA SPL set id549185
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-03-31
Marketing effective time low2017-08-15
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 25021-186

NDC Item 44567021010

NDC 944567-210
NDC 1044567-210-10
NDC Item44567021010
Packaging10 VIAL in 1 CARTON (44567-210-10) / 10 mL in 1 VIAL
ANDAANDA065176
FDA SPL set id803837
LabelerWG Critical Care, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 44567-210

NDC Item 55150011601

NDC 955150-116
NDC 1055150-116-01
NDC Item55150011601
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011610

NDC 955150-116
NDC 1055150-116-10
NDC Item55150011610
Packaging10 VIAL in 1 CARTON (55150-116-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011620

NDC 955150-116
NDC 1055150-116-20
NDC Item55150011620
Packaging10 VIAL in 1 CARTON (55150-116-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150017899

NDC 955150-178
NDC 1055150-178-99
NDC Item55150017899
Packaging10 BOTTLE in 1 BOX (55150-178-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE
ANDAANDA090340
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-09-13
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-178

NDC Item 63323036820

NDC 963323-368
NDC 1063323-368-20
NDC Item63323036820
Packaging10 VIAL in 1 CARTON (63323-368-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065222
FDA SPL set id460623
LabelerFresenius Kabi USA, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2016-05-05
Marketing effective time low2005-11-29
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 63323-368

NDC Item 66794020602

NDC 966794-206
NDC 1066794-206-02
NDC Item66794020602
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794020641

NDC 966794-206
NDC 1066794-206-41
NDC Item66794020641
Packaging10 VIAL in 1 CARTON (66794-206-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-206-02)
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794024102

NDC 966794-241
NDC 1066794-241-02
NDC Item66794024102
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 66794024141

NDC 966794-241
NDC 1066794-241-41
NDC Item66794024141
Packaging10 VIAL in 1 CARTON (66794-241-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-241-02)
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 67457034810

NDC 967457-348
NDC 1067457-348-10
NDC Item67457034810
Packaging10 VIAL in 1 CARTON (67457-348-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67457034815

NDC 967457-348
NDC 1067457-348-15
NDC Item67457034815
Packaging1 VIAL in 1 CARTON (67457-348-15) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67850013000

NDC 967850-130
NDC 1067850-130-00
NDC Item67850013000
Packaging1 in 1 VIAL, GLASS
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 67850013010

NDC 967850-130
NDC 1067850-130-10
NDC Item67850013010
Packaging10 VIAL, GLASS in 1 CARTON (67850-130-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (67850-130-00)
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 70594008101

NDC 970594-081
NDC 1070594-081-01
NDC Item70594008101
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 70594008102

NDC 970594-081
NDC 1070594-081-02
NDC Item70594008102
Packaging10 VIAL in 1 CARTON (70594-081-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-081-01)
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 71288000520

NDC 971288-005
NDC 1071288-005-20
NDC Item71288000520
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-005-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-005-21)
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288000521

NDC 971288-005
NDC 1071288-005-21
NDC Item71288000521
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288003120

NDC 971288-031
NDC 1071288-031-20
NDC Item71288003120
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003121

NDC 971288-031
NDC 1071288-031-21
NDC Item71288003121
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-21) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-20)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003191

NDC 971288-031
NDC 1071288-031-91
NDC Item71288003191
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003192

NDC 971288-031
NDC 1071288-031-92
NDC Item71288003192
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-92) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-91)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 72485041601

NDC 972485-416
NDC 1072485-416-01
NDC Item72485041601
Packaging1 in 1 VIAL
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72485041610

NDC 972485-416
NDC 1072485-416-10
NDC Item72485041610
Packaging10 VIAL in 1 CARTON (72485-416-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72485-416-01)
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72572002101

NDC 972572-021
NDC 1072572-021-01
NDC Item72572002101
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72572002110

NDC 972572-021
NDC 1072572-021-10
NDC Item72572002110
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72572-021-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72572-021-01)
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72603022001

NDC 972603-220
NDC 1072603-220-01
NDC Item72603022001
Packaging1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusactive
Related queriesProperties for NDC 9 72603-220

NDC Item 72603022010

NDC 972603-220
NDC 1072603-220-10
NDC Item72603022010
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72603-220-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 72603-220

NDC Item 82449051301

NDC 982449-513
NDC 1082449-513-01
NDC Item82449051301
Packaging1 VIAL in 1 CARTON (82449-513-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 82449051302

NDC 982449-513
NDC 1082449-513-02
NDC Item82449051302
Packaging10 VIAL in 1 CARTON (82449-513-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 00409268901

NDC 90409-2689
NDC 100409-2689-01
NDC Item00409268901
Packaging10 VIAL in 1 TRAY (0409-2689-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0409-2689-21)
ANDAANDA065310
FDA SPL set id806154
LabelerHospira, Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-07-25
Marketing statusACTIVE
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268921

NDC 90409-2689
NDC 100409-2689-21
NDC Item00409268921
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268949

NDC 90409-2689
NDC 100409-2689-49
NDC Item00409268949
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00641611601

NDC 90641-6116
NDC 100641-6116-01
NDC Item00641611601
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611610

NDC 90641-6116
NDC 100641-6116-10
NDC Item00641611610
Packaging10 VIAL in 1 CARTON (0641-6116-10) / 1.5 g in 1 VIAL (0641-6116-01)
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611901

NDC 90641-6119
NDC 100641-6119-01
NDC Item00641611901
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641611910

NDC 90641-6119
NDC 100641-6119-10
NDC Item00641611910
Packaging10 VIAL in 1 CARTON (0641-6119-10) / 1.5 g in 1 VIAL (0641-6119-01)
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641612201

NDC 90641-6122
NDC 100641-6122-01
NDC Item00641612201
Packaging4 mL in 1 VIAL
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00641612210

NDC 90641-6122
NDC 100641-6122-10
NDC Item00641612210
Packaging10 VIAL in 1 CARTON (0641-6122-10) / 4 mL in 1 VIAL (0641-6122-01)
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00781303270

NDC 90781-3032
NDC 100781-3032-70
NDC Item00781303270
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 00781303295

NDC 90781-3032
NDC 100781-3032-95
NDC Item00781303295
Packaging10 VIAL in 1 CARTON (0781-3032-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-3032-70)
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 25021014220

NDC 925021-142
NDC 1025021-142-20
NDC Item25021014220
Packaging10 VIAL in 1 CARTON (25021-142-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065406
FDA SPL set id612973
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-06-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 25021-142

NDC Item 25021018620

NDC 925021-186
NDC 1025021-186-20
NDC Item25021018620
Packaging10 VIAL in 1 CARTON (25021-186-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090579
FDA SPL set id549185
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-03-31
Marketing effective time low2017-08-15
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 25021-186

NDC Item 44567021010

NDC 944567-210
NDC 1044567-210-10
NDC Item44567021010
Packaging10 VIAL in 1 CARTON (44567-210-10) / 10 mL in 1 VIAL
ANDAANDA065176
FDA SPL set id803837
LabelerWG Critical Care, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 44567-210

NDC Item 55150011601

NDC 955150-116
NDC 1055150-116-01
NDC Item55150011601
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011610

NDC 955150-116
NDC 1055150-116-10
NDC Item55150011610
Packaging10 VIAL in 1 CARTON (55150-116-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011620

NDC 955150-116
NDC 1055150-116-20
NDC Item55150011620
Packaging10 VIAL in 1 CARTON (55150-116-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150017899

NDC 955150-178
NDC 1055150-178-99
NDC Item55150017899
Packaging10 BOTTLE in 1 BOX (55150-178-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE
ANDAANDA090340
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-09-13
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-178

NDC Item 63323036820

NDC 963323-368
NDC 1063323-368-20
NDC Item63323036820
Packaging10 VIAL in 1 CARTON (63323-368-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065222
FDA SPL set id460623
LabelerFresenius Kabi USA, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2016-05-05
Marketing effective time low2005-11-29
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 63323-368

NDC Item 66794020602

NDC 966794-206
NDC 1066794-206-02
NDC Item66794020602
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794020641

NDC 966794-206
NDC 1066794-206-41
NDC Item66794020641
Packaging10 VIAL in 1 CARTON (66794-206-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-206-02)
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794024102

NDC 966794-241
NDC 1066794-241-02
NDC Item66794024102
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 66794024141

NDC 966794-241
NDC 1066794-241-41
NDC Item66794024141
Packaging10 VIAL in 1 CARTON (66794-241-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-241-02)
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 67457034810

NDC 967457-348
NDC 1067457-348-10
NDC Item67457034810
Packaging10 VIAL in 1 CARTON (67457-348-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67457034815

NDC 967457-348
NDC 1067457-348-15
NDC Item67457034815
Packaging1 VIAL in 1 CARTON (67457-348-15) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67850013000

NDC 967850-130
NDC 1067850-130-00
NDC Item67850013000
Packaging1 in 1 VIAL, GLASS
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 67850013010

NDC 967850-130
NDC 1067850-130-10
NDC Item67850013010
Packaging10 VIAL, GLASS in 1 CARTON (67850-130-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (67850-130-00)
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 70594008101

NDC 970594-081
NDC 1070594-081-01
NDC Item70594008101
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 70594008102

NDC 970594-081
NDC 1070594-081-02
NDC Item70594008102
Packaging10 VIAL in 1 CARTON (70594-081-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-081-01)
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 71288000520

NDC 971288-005
NDC 1071288-005-20
NDC Item71288000520
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-005-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-005-21)
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288000521

NDC 971288-005
NDC 1071288-005-21
NDC Item71288000521
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288003120

NDC 971288-031
NDC 1071288-031-20
NDC Item71288003120
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003121

NDC 971288-031
NDC 1071288-031-21
NDC Item71288003121
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-21) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-20)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003191

NDC 971288-031
NDC 1071288-031-91
NDC Item71288003191
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003192

NDC 971288-031
NDC 1071288-031-92
NDC Item71288003192
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-92) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-91)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 72485041601

NDC 972485-416
NDC 1072485-416-01
NDC Item72485041601
Packaging1 in 1 VIAL
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72485041610

NDC 972485-416
NDC 1072485-416-10
NDC Item72485041610
Packaging10 VIAL in 1 CARTON (72485-416-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72485-416-01)
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72572002101

NDC 972572-021
NDC 1072572-021-01
NDC Item72572002101
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72572002110

NDC 972572-021
NDC 1072572-021-10
NDC Item72572002110
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72572-021-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72572-021-01)
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72603022001

NDC 972603-220
NDC 1072603-220-01
NDC Item72603022001
Packaging1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusactive
Related queriesProperties for NDC 9 72603-220

NDC Item 72603022010

NDC 972603-220
NDC 1072603-220-10
NDC Item72603022010
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72603-220-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 72603-220

NDC Item 82449051301

NDC 982449-513
NDC 1082449-513-01
NDC Item82449051301
Packaging1 VIAL in 1 CARTON (82449-513-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 82449051302

NDC 982449-513
NDC 1082449-513-02
NDC Item82449051302
Packaging10 VIAL in 1 CARTON (82449-513-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 00409268901

NDC 90409-2689
NDC 100409-2689-01
NDC Item00409268901
Packaging10 VIAL in 1 TRAY (0409-2689-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0409-2689-21)
ANDAANDA065310
FDA SPL set id806154
LabelerHospira, Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-07-25
Marketing statusACTIVE
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268921

NDC 90409-2689
NDC 100409-2689-21
NDC Item00409268921
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268949

NDC 90409-2689
NDC 100409-2689-49
NDC Item00409268949
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00641611601

NDC 90641-6116
NDC 100641-6116-01
NDC Item00641611601
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611610

NDC 90641-6116
NDC 100641-6116-10
NDC Item00641611610
Packaging10 VIAL in 1 CARTON (0641-6116-10) / 1.5 g in 1 VIAL (0641-6116-01)
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611901

NDC 90641-6119
NDC 100641-6119-01
NDC Item00641611901
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641611910

NDC 90641-6119
NDC 100641-6119-10
NDC Item00641611910
Packaging10 VIAL in 1 CARTON (0641-6119-10) / 1.5 g in 1 VIAL (0641-6119-01)
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641612201

NDC 90641-6122
NDC 100641-6122-01
NDC Item00641612201
Packaging4 mL in 1 VIAL
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00641612210

NDC 90641-6122
NDC 100641-6122-10
NDC Item00641612210
Packaging10 VIAL in 1 CARTON (0641-6122-10) / 4 mL in 1 VIAL (0641-6122-01)
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00781303270

NDC 90781-3032
NDC 100781-3032-70
NDC Item00781303270
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 00781303295

NDC 90781-3032
NDC 100781-3032-95
NDC Item00781303295
Packaging10 VIAL in 1 CARTON (0781-3032-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-3032-70)
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 25021014220

NDC 925021-142
NDC 1025021-142-20
NDC Item25021014220
Packaging10 VIAL in 1 CARTON (25021-142-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065406
FDA SPL set id612973
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-06-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 25021-142

NDC Item 25021018620

NDC 925021-186
NDC 1025021-186-20
NDC Item25021018620
Packaging10 VIAL in 1 CARTON (25021-186-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090579
FDA SPL set id549185
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-03-31
Marketing effective time low2017-08-15
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 25021-186

NDC Item 44567021010

NDC 944567-210
NDC 1044567-210-10
NDC Item44567021010
Packaging10 VIAL in 1 CARTON (44567-210-10) / 10 mL in 1 VIAL
ANDAANDA065176
FDA SPL set id803837
LabelerWG Critical Care, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 44567-210

NDC Item 55150011601

NDC 955150-116
NDC 1055150-116-01
NDC Item55150011601
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011610

NDC 955150-116
NDC 1055150-116-10
NDC Item55150011610
Packaging10 VIAL in 1 CARTON (55150-116-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011620

NDC 955150-116
NDC 1055150-116-20
NDC Item55150011620
Packaging10 VIAL in 1 CARTON (55150-116-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150017899

NDC 955150-178
NDC 1055150-178-99
NDC Item55150017899
Packaging10 BOTTLE in 1 BOX (55150-178-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE
ANDAANDA090340
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-09-13
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-178

NDC Item 63323036820

NDC 963323-368
NDC 1063323-368-20
NDC Item63323036820
Packaging10 VIAL in 1 CARTON (63323-368-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065222
FDA SPL set id460623
LabelerFresenius Kabi USA, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2016-05-05
Marketing effective time low2005-11-29
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 63323-368

NDC Item 66794020602

NDC 966794-206
NDC 1066794-206-02
NDC Item66794020602
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794020641

NDC 966794-206
NDC 1066794-206-41
NDC Item66794020641
Packaging10 VIAL in 1 CARTON (66794-206-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-206-02)
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794024102

NDC 966794-241
NDC 1066794-241-02
NDC Item66794024102
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 66794024141

NDC 966794-241
NDC 1066794-241-41
NDC Item66794024141
Packaging10 VIAL in 1 CARTON (66794-241-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-241-02)
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 67457034810

NDC 967457-348
NDC 1067457-348-10
NDC Item67457034810
Packaging10 VIAL in 1 CARTON (67457-348-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67457034815

NDC 967457-348
NDC 1067457-348-15
NDC Item67457034815
Packaging1 VIAL in 1 CARTON (67457-348-15) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67850013000

NDC 967850-130
NDC 1067850-130-00
NDC Item67850013000
Packaging1 in 1 VIAL, GLASS
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 67850013010

NDC 967850-130
NDC 1067850-130-10
NDC Item67850013010
Packaging10 VIAL, GLASS in 1 CARTON (67850-130-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (67850-130-00)
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 70594008101

NDC 970594-081
NDC 1070594-081-01
NDC Item70594008101
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 70594008102

NDC 970594-081
NDC 1070594-081-02
NDC Item70594008102
Packaging10 VIAL in 1 CARTON (70594-081-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-081-01)
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 71288000520

NDC 971288-005
NDC 1071288-005-20
NDC Item71288000520
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-005-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-005-21)
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288000521

NDC 971288-005
NDC 1071288-005-21
NDC Item71288000521
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288003120

NDC 971288-031
NDC 1071288-031-20
NDC Item71288003120
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003121

NDC 971288-031
NDC 1071288-031-21
NDC Item71288003121
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-21) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-20)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003191

NDC 971288-031
NDC 1071288-031-91
NDC Item71288003191
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003192

NDC 971288-031
NDC 1071288-031-92
NDC Item71288003192
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-92) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-91)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 72485041601

NDC 972485-416
NDC 1072485-416-01
NDC Item72485041601
Packaging1 in 1 VIAL
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72485041610

NDC 972485-416
NDC 1072485-416-10
NDC Item72485041610
Packaging10 VIAL in 1 CARTON (72485-416-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72485-416-01)
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72572002101

NDC 972572-021
NDC 1072572-021-01
NDC Item72572002101
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72572002110

NDC 972572-021
NDC 1072572-021-10
NDC Item72572002110
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72572-021-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72572-021-01)
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72603022001

NDC 972603-220
NDC 1072603-220-01
NDC Item72603022001
Packaging1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusactive
Related queriesProperties for NDC 9 72603-220

NDC Item 72603022010

NDC 972603-220
NDC 1072603-220-10
NDC Item72603022010
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72603-220-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 72603-220

NDC Item 82449051301

NDC 982449-513
NDC 1082449-513-01
NDC Item82449051301
Packaging1 VIAL in 1 CARTON (82449-513-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 82449051302

NDC 982449-513
NDC 1082449-513-02
NDC Item82449051302
Packaging10 VIAL in 1 CARTON (82449-513-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 00409268901

NDC 90409-2689
NDC 100409-2689-01
NDC Item00409268901
Packaging10 VIAL in 1 TRAY (0409-2689-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0409-2689-21)
ANDAANDA065310
FDA SPL set id806154
LabelerHospira, Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-07-25
Marketing statusACTIVE
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268921

NDC 90409-2689
NDC 100409-2689-21
NDC Item00409268921
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268949

NDC 90409-2689
NDC 100409-2689-49
NDC Item00409268949
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00641611601

NDC 90641-6116
NDC 100641-6116-01
NDC Item00641611601
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611610

NDC 90641-6116
NDC 100641-6116-10
NDC Item00641611610
Packaging10 VIAL in 1 CARTON (0641-6116-10) / 1.5 g in 1 VIAL (0641-6116-01)
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611901

NDC 90641-6119
NDC 100641-6119-01
NDC Item00641611901
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641611910

NDC 90641-6119
NDC 100641-6119-10
NDC Item00641611910
Packaging10 VIAL in 1 CARTON (0641-6119-10) / 1.5 g in 1 VIAL (0641-6119-01)
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641612201

NDC 90641-6122
NDC 100641-6122-01
NDC Item00641612201
Packaging4 mL in 1 VIAL
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00641612210

NDC 90641-6122
NDC 100641-6122-10
NDC Item00641612210
Packaging10 VIAL in 1 CARTON (0641-6122-10) / 4 mL in 1 VIAL (0641-6122-01)
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00781303270

NDC 90781-3032
NDC 100781-3032-70
NDC Item00781303270
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 00781303295

NDC 90781-3032
NDC 100781-3032-95
NDC Item00781303295
Packaging10 VIAL in 1 CARTON (0781-3032-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-3032-70)
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 25021014220

NDC 925021-142
NDC 1025021-142-20
NDC Item25021014220
Packaging10 VIAL in 1 CARTON (25021-142-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065406
FDA SPL set id612973
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-06-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 25021-142

NDC Item 25021018620

NDC 925021-186
NDC 1025021-186-20
NDC Item25021018620
Packaging10 VIAL in 1 CARTON (25021-186-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090579
FDA SPL set id549185
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-03-31
Marketing effective time low2017-08-15
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 25021-186

NDC Item 44567021010

NDC 944567-210
NDC 1044567-210-10
NDC Item44567021010
Packaging10 VIAL in 1 CARTON (44567-210-10) / 10 mL in 1 VIAL
ANDAANDA065176
FDA SPL set id803837
LabelerWG Critical Care, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 44567-210

NDC Item 55150011601

NDC 955150-116
NDC 1055150-116-01
NDC Item55150011601
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011610

NDC 955150-116
NDC 1055150-116-10
NDC Item55150011610
Packaging10 VIAL in 1 CARTON (55150-116-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011620

NDC 955150-116
NDC 1055150-116-20
NDC Item55150011620
Packaging10 VIAL in 1 CARTON (55150-116-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150017899

NDC 955150-178
NDC 1055150-178-99
NDC Item55150017899
Packaging10 BOTTLE in 1 BOX (55150-178-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE
ANDAANDA090340
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-09-13
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-178

NDC Item 63323036820

NDC 963323-368
NDC 1063323-368-20
NDC Item63323036820
Packaging10 VIAL in 1 CARTON (63323-368-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065222
FDA SPL set id460623
LabelerFresenius Kabi USA, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2016-05-05
Marketing effective time low2005-11-29
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 63323-368

NDC Item 66794020602

NDC 966794-206
NDC 1066794-206-02
NDC Item66794020602
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794020641

NDC 966794-206
NDC 1066794-206-41
NDC Item66794020641
Packaging10 VIAL in 1 CARTON (66794-206-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-206-02)
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794024102

NDC 966794-241
NDC 1066794-241-02
NDC Item66794024102
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 66794024141

NDC 966794-241
NDC 1066794-241-41
NDC Item66794024141
Packaging10 VIAL in 1 CARTON (66794-241-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-241-02)
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 67457034810

NDC 967457-348
NDC 1067457-348-10
NDC Item67457034810
Packaging10 VIAL in 1 CARTON (67457-348-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67457034815

NDC 967457-348
NDC 1067457-348-15
NDC Item67457034815
Packaging1 VIAL in 1 CARTON (67457-348-15) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67850013000

NDC 967850-130
NDC 1067850-130-00
NDC Item67850013000
Packaging1 in 1 VIAL, GLASS
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 67850013010

NDC 967850-130
NDC 1067850-130-10
NDC Item67850013010
Packaging10 VIAL, GLASS in 1 CARTON (67850-130-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (67850-130-00)
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 70594008101

NDC 970594-081
NDC 1070594-081-01
NDC Item70594008101
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 70594008102

NDC 970594-081
NDC 1070594-081-02
NDC Item70594008102
Packaging10 VIAL in 1 CARTON (70594-081-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-081-01)
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 71288000520

NDC 971288-005
NDC 1071288-005-20
NDC Item71288000520
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-005-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-005-21)
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288000521

NDC 971288-005
NDC 1071288-005-21
NDC Item71288000521
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288003120

NDC 971288-031
NDC 1071288-031-20
NDC Item71288003120
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003121

NDC 971288-031
NDC 1071288-031-21
NDC Item71288003121
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-21) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-20)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003191

NDC 971288-031
NDC 1071288-031-91
NDC Item71288003191
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003192

NDC 971288-031
NDC 1071288-031-92
NDC Item71288003192
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-92) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-91)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 72485041601

NDC 972485-416
NDC 1072485-416-01
NDC Item72485041601
Packaging1 in 1 VIAL
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72485041610

NDC 972485-416
NDC 1072485-416-10
NDC Item72485041610
Packaging10 VIAL in 1 CARTON (72485-416-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72485-416-01)
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72572002101

NDC 972572-021
NDC 1072572-021-01
NDC Item72572002101
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72572002110

NDC 972572-021
NDC 1072572-021-10
NDC Item72572002110
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72572-021-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72572-021-01)
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72603022001

NDC 972603-220
NDC 1072603-220-01
NDC Item72603022001
Packaging1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusactive
Related queriesProperties for NDC 9 72603-220

NDC Item 72603022010

NDC 972603-220
NDC 1072603-220-10
NDC Item72603022010
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72603-220-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 72603-220

NDC Item 82449051301

NDC 982449-513
NDC 1082449-513-01
NDC Item82449051301
Packaging1 VIAL in 1 CARTON (82449-513-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 82449051302

NDC 982449-513
NDC 1082449-513-02
NDC Item82449051302
Packaging10 VIAL in 1 CARTON (82449-513-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 00409268901

NDC 90409-2689
NDC 100409-2689-01
NDC Item00409268901
Packaging10 VIAL in 1 TRAY (0409-2689-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0409-2689-21)
ANDAANDA065310
FDA SPL set id806154
LabelerHospira, Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-07-25
Marketing statusACTIVE
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268921

NDC 90409-2689
NDC 100409-2689-21
NDC Item00409268921
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268949

NDC 90409-2689
NDC 100409-2689-49
NDC Item00409268949
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00641611601

NDC 90641-6116
NDC 100641-6116-01
NDC Item00641611601
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611610

NDC 90641-6116
NDC 100641-6116-10
NDC Item00641611610
Packaging10 VIAL in 1 CARTON (0641-6116-10) / 1.5 g in 1 VIAL (0641-6116-01)
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611901

NDC 90641-6119
NDC 100641-6119-01
NDC Item00641611901
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641611910

NDC 90641-6119
NDC 100641-6119-10
NDC Item00641611910
Packaging10 VIAL in 1 CARTON (0641-6119-10) / 1.5 g in 1 VIAL (0641-6119-01)
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641612201

NDC 90641-6122
NDC 100641-6122-01
NDC Item00641612201
Packaging4 mL in 1 VIAL
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00641612210

NDC 90641-6122
NDC 100641-6122-10
NDC Item00641612210
Packaging10 VIAL in 1 CARTON (0641-6122-10) / 4 mL in 1 VIAL (0641-6122-01)
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00781303270

NDC 90781-3032
NDC 100781-3032-70
NDC Item00781303270
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 00781303295

NDC 90781-3032
NDC 100781-3032-95
NDC Item00781303295
Packaging10 VIAL in 1 CARTON (0781-3032-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-3032-70)
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 25021014220

NDC 925021-142
NDC 1025021-142-20
NDC Item25021014220
Packaging10 VIAL in 1 CARTON (25021-142-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065406
FDA SPL set id612973
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-06-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 25021-142

NDC Item 25021018620

NDC 925021-186
NDC 1025021-186-20
NDC Item25021018620
Packaging10 VIAL in 1 CARTON (25021-186-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090579
FDA SPL set id549185
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-03-31
Marketing effective time low2017-08-15
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 25021-186

NDC Item 44567021010

NDC 944567-210
NDC 1044567-210-10
NDC Item44567021010
Packaging10 VIAL in 1 CARTON (44567-210-10) / 10 mL in 1 VIAL
ANDAANDA065176
FDA SPL set id803837
LabelerWG Critical Care, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 44567-210

NDC Item 55150011601

NDC 955150-116
NDC 1055150-116-01
NDC Item55150011601
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011610

NDC 955150-116
NDC 1055150-116-10
NDC Item55150011610
Packaging10 VIAL in 1 CARTON (55150-116-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011620

NDC 955150-116
NDC 1055150-116-20
NDC Item55150011620
Packaging10 VIAL in 1 CARTON (55150-116-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150017899

NDC 955150-178
NDC 1055150-178-99
NDC Item55150017899
Packaging10 BOTTLE in 1 BOX (55150-178-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE
ANDAANDA090340
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-09-13
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-178

NDC Item 63323036820

NDC 963323-368
NDC 1063323-368-20
NDC Item63323036820
Packaging10 VIAL in 1 CARTON (63323-368-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065222
FDA SPL set id460623
LabelerFresenius Kabi USA, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2016-05-05
Marketing effective time low2005-11-29
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 63323-368

NDC Item 66794020602

NDC 966794-206
NDC 1066794-206-02
NDC Item66794020602
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794020641

NDC 966794-206
NDC 1066794-206-41
NDC Item66794020641
Packaging10 VIAL in 1 CARTON (66794-206-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-206-02)
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794024102

NDC 966794-241
NDC 1066794-241-02
NDC Item66794024102
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 66794024141

NDC 966794-241
NDC 1066794-241-41
NDC Item66794024141
Packaging10 VIAL in 1 CARTON (66794-241-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-241-02)
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 67457034810

NDC 967457-348
NDC 1067457-348-10
NDC Item67457034810
Packaging10 VIAL in 1 CARTON (67457-348-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67457034815

NDC 967457-348
NDC 1067457-348-15
NDC Item67457034815
Packaging1 VIAL in 1 CARTON (67457-348-15) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67850013000

NDC 967850-130
NDC 1067850-130-00
NDC Item67850013000
Packaging1 in 1 VIAL, GLASS
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 67850013010

NDC 967850-130
NDC 1067850-130-10
NDC Item67850013010
Packaging10 VIAL, GLASS in 1 CARTON (67850-130-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (67850-130-00)
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 70594008101

NDC 970594-081
NDC 1070594-081-01
NDC Item70594008101
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 70594008102

NDC 970594-081
NDC 1070594-081-02
NDC Item70594008102
Packaging10 VIAL in 1 CARTON (70594-081-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-081-01)
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 71288000520

NDC 971288-005
NDC 1071288-005-20
NDC Item71288000520
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-005-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-005-21)
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288000521

NDC 971288-005
NDC 1071288-005-21
NDC Item71288000521
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288003120

NDC 971288-031
NDC 1071288-031-20
NDC Item71288003120
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003121

NDC 971288-031
NDC 1071288-031-21
NDC Item71288003121
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-21) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-20)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003191

NDC 971288-031
NDC 1071288-031-91
NDC Item71288003191
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 71288003192

NDC 971288-031
NDC 1071288-031-92
NDC Item71288003192
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-92) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-91)
ANDAANDA065222
FDA SPL set id749843
FDA SPL set id787470
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-29
Marketing statusACTIVE
Related queriesProperties for NDC 9 71288-031

NDC Item 72485041601

NDC 972485-416
NDC 1072485-416-01
NDC Item72485041601
Packaging1 in 1 VIAL
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72485041610

NDC 972485-416
NDC 1072485-416-10
NDC Item72485041610
Packaging10 VIAL in 1 CARTON (72485-416-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72485-416-01)
ANDAANDA201024
COLORTEXTwhite(off-white)
ColorC48325 __
FDA SPL set id720326
LabelerArmas Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-07-21
Marketing statusACTIVE
Related queriesProperties for NDC 9 72485-416

NDC Item 72572002101

NDC 972572-021
NDC 1072572-021-01
NDC Item72572002101
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72572002110

NDC 972572-021
NDC 1072572-021-10
NDC Item72572002110
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72572-021-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72572-021-01)
ANDAANDA090579
FDA SPL set id679256
LabelerCivica, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-03-11
Marketing effective time low2022-01-10
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 72572-021

NDC Item 72603022001

NDC 972603-220
NDC 1072603-220-01
NDC Item72603022001
Packaging1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusactive
Related queriesProperties for NDC 9 72603-220

NDC Item 72603022010

NDC 972603-220
NDC 1072603-220-10
NDC Item72603022010
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (72603-220-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
ANDAANDA065222
FDA SPL set id793796
LabelerNorthStar Rx, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-03-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 72603-220

NDC Item 82449051301

NDC 982449-513
NDC 1082449-513-01
NDC Item82449051301
Packaging1 VIAL in 1 CARTON (82449-513-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 82449051302

NDC 982449-513
NDC 1082449-513-02
NDC Item82449051302
Packaging10 VIAL in 1 CARTON (82449-513-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id803546
LabelerSteriscience Specialties Private Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-04-14
Marketing statusACTIVE
Related queriesProperties for NDC 9 82449-513

NDC Item 00409268901

NDC 90409-2689
NDC 100409-2689-01
NDC Item00409268901
Packaging10 VIAL in 1 TRAY (0409-2689-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0409-2689-21)
ANDAANDA065310
FDA SPL set id806154
LabelerHospira, Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-07-25
Marketing statusACTIVE
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268921

NDC 90409-2689
NDC 100409-2689-21
NDC Item00409268921
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00409268949

NDC 90409-2689
NDC 100409-2689-49
NDC Item00409268949
ANDAANDA065241
FDA SPL set id806154
LabelerHospira, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-01
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0409-2689

NDC Item 00641611601

NDC 90641-6116
NDC 100641-6116-01
NDC Item00641611601
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611610

NDC 90641-6116
NDC 100641-6116-10
NDC Item00641611610
Packaging10 VIAL in 1 CARTON (0641-6116-10) / 1.5 g in 1 VIAL (0641-6116-01)
ANDAANDA065406
FDA SPL set id811866
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6116

NDC Item 00641611901

NDC 90641-6119
NDC 100641-6119-01
NDC Item00641611901
Packaging1.5 g in 1 VIAL
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641611910

NDC 90641-6119
NDC 100641-6119-10
NDC Item00641611910
Packaging10 VIAL in 1 CARTON (0641-6119-10) / 1.5 g in 1 VIAL (0641-6119-01)
ANDAANDA065406
FDA SPL set id440588
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6119

NDC Item 00641612201

NDC 90641-6122
NDC 100641-6122-01
NDC Item00641612201
Packaging4 mL in 1 VIAL
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00641612210

NDC 90641-6122
NDC 100641-6122-10
NDC Item00641612210
Packaging10 VIAL in 1 CARTON (0641-6122-10) / 4 mL in 1 VIAL (0641-6122-01)
ANDAANDA065406
FDA SPL set id440293
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2009-12-22
Marketing statusACTIVE
Related queriesProperties for NDC 9 0641-6122

NDC Item 00781303270

NDC 90781-3032
NDC 100781-3032-70
NDC Item00781303270
Packaging1 in 1 VIAL
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 00781303295

NDC 90781-3032
NDC 100781-3032-95
NDC Item00781303295
Packaging10 VIAL in 1 CARTON (0781-3032-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-3032-70)
ANDAANDA065241
FDA SPL set id526593
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2020-05-31
Marketing effective time low2006-07-25
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 0781-3032

NDC Item 25021014220

NDC 925021-142
NDC 1025021-142-20
NDC Item25021014220
Packaging10 VIAL in 1 CARTON (25021-142-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065406
FDA SPL set id612973
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-06-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 25021-142

NDC Item 25021018620

NDC 925021-186
NDC 1025021-186-20
NDC Item25021018620
Packaging10 VIAL in 1 CARTON (25021-186-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090579
FDA SPL set id549185
LabelerSagent Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-03-31
Marketing effective time low2017-08-15
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 25021-186

NDC Item 44567021010

NDC 944567-210
NDC 1044567-210-10
NDC Item44567021010
Packaging10 VIAL in 1 CARTON (44567-210-10) / 10 mL in 1 VIAL
ANDAANDA065176
FDA SPL set id803837
LabelerWG Critical Care, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2005-11-30
Marketing statusACTIVE
Related queriesProperties for NDC 9 44567-210

NDC Item 55150011601

NDC 955150-116
NDC 1055150-116-01
NDC Item55150011601
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011610

NDC 955150-116
NDC 1055150-116-10
NDC Item55150011610
Packaging10 VIAL in 1 CARTON (55150-116-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150011620

NDC 955150-116
NDC 1055150-116-20
NDC Item55150011620
Packaging10 VIAL in 1 CARTON (55150-116-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA090349
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id705782
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-02-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-116

NDC Item 55150017899

NDC 955150-178
NDC 1055150-178-99
NDC Item55150017899
Packaging10 BOTTLE in 1 BOX (55150-178-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE
ANDAANDA090340
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id790857
LabelerEugia US LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-09-13
Marketing statusACTIVE
Related queriesProperties for NDC 9 55150-178

NDC Item 63323036820

NDC 963323-368
NDC 1063323-368-20
NDC Item63323036820
Packaging10 VIAL in 1 CARTON (63323-368-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA065222
FDA SPL set id460623
LabelerFresenius Kabi USA, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2016-05-05
Marketing effective time low2005-11-29
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 63323-368

NDC Item 66794020602

NDC 966794-206
NDC 1066794-206-02
NDC Item66794020602
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794020641

NDC 966794-206
NDC 1066794-206-41
NDC Item66794020641
Packaging10 VIAL in 1 CARTON (66794-206-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-206-02)
ANDAANDA090579
FDA SPL set id683064
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2019-05-20
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-206

NDC Item 66794024102

NDC 966794-241
NDC 1066794-241-02
NDC Item66794024102
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 66794024141

NDC 966794-241
NDC 1066794-241-41
NDC Item66794024141
Packaging10 VIAL in 1 CARTON (66794-241-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-241-02)
ANDAANDA090579
FDA SPL set id695619
LabelerPiramal Critical Care Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-05-15
Marketing effective time low2023-01-01
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 66794-241

NDC Item 67457034810

NDC 967457-348
NDC 1067457-348-10
NDC Item67457034810
Packaging10 VIAL in 1 CARTON (67457-348-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67457034815

NDC 967457-348
NDC 1067457-348-15
NDC Item67457034815
Packaging1 VIAL in 1 CARTON (67457-348-15) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ANDAANDA201024
FDA SPL set id544815
LabelerMylan Institutional LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-10-31
Marketing effective time low2014-04-08
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 67457-348

NDC Item 67850013000

NDC 967850-130
NDC 1067850-130-00
NDC Item67850013000
Packaging1 in 1 VIAL, GLASS
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 67850013010

NDC 967850-130
NDC 1067850-130-10
NDC Item67850013010
Packaging10 VIAL, GLASS in 1 CARTON (67850-130-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (67850-130-00)
ANDAANDA201406
FDA SPL set id770928
LabelerMethapharm, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-01
Marketing statusACTIVE
Related queriesProperties for NDC 9 67850-130

NDC Item 70594008101

NDC 970594-081
NDC 1070594-081-01
NDC Item70594008101
Packaging1 in 1 VIAL
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 70594008102

NDC 970594-081
NDC 1070594-081-02
NDC Item70594008102
Packaging10 VIAL in 1 CARTON (70594-081-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-081-01)
ANDAANDA090579
FDA SPL set id687752
LabelerXellia Pharmaceuticals USA LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-10
Marketing statusACTIVE
Related queriesProperties for NDC 9 70594-081

NDC Item 71288000520

NDC 971288-005
NDC 1071288-005-20
NDC Item71288000520
Packaging10 VIAL, SINGLE-DOSE in 1 CARTON (71288-005-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-005-21)
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288000521

NDC 971288-005
NDC 1071288-005-21
NDC Item71288000521
Packaging1 in 1 VIAL, SINGLE-DOSE
ANDAANDA090579
FDA SPL set id770198
LabelerMeitheal Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-07-31
Marketing effective time low2022-01-17
Marketing statusCOMPLETED
Related queriesProperties for NDC 9 71288-005

NDC Item 71288003120