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NDC properties for NDC 9 0591-2422

NDC item 00591242212

NDC 90591-2422
NDC 100591-2422-12
NDC Item00591242212
packaging1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER
ANDAANDA201949
LabelerActavis Pharma, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-11-30
Marketing effective time low2022-10-07
Marketing statusCOMPLETED

NDC item 00591242226

NDC 90591-2422
NDC 100591-2422-26
NDC Item00591242226
packaging1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER
ANDAANDA201949
LabelerActavis Pharma, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-11-30
Marketing effective time low2022-10-07
Marketing statusCOMPLETED

NDC item 00591242279

NDC 90591-2422
NDC 100591-2422-79
NDC Item00591242279
packaging1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER
ANDAANDA201949
LabelerActavis Pharma, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2024-11-30
Marketing effective time low2022-10-07
Marketing statusCOMPLETED

NDC item 00781718670

NDC 90781-7186
NDC 100781-7186-70
NDC Item00781718670
packaging10 mL in 1 BOTTLE, DROPPER (0781-7186-70)
ANDAANDA091087
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-04-13
Marketing statusACTIVE

NDC item 00781718675

NDC 90781-7186
NDC 100781-7186-75
NDC Item00781718675
packaging5 mL in 1 BOTTLE, DROPPER (0781-7186-75)
ANDAANDA091087
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-04-13
Marketing statusACTIVE

NDC item 00781718685

NDC 90781-7186
NDC 100781-7186-85
NDC Item00781718685
packaging15 mL in 1 BOTTLE, DROPPER (0781-7186-85)
ANDAANDA091087
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-04-13
Marketing statusACTIVE

NDC item 00832142505

NDC 90832-1425
NDC 100832-1425-05
NDC Item00832142505
packaging1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER
ANDAANDA215598
LabelerUpsher-Smith Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-12-15
Marketing statusACTIVE

NDC item 00832142510

NDC 90832-1425
NDC 100832-1425-10
NDC Item00832142510
packaging1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER
ANDAANDA215598
LabelerUpsher-Smith Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-12-15
Marketing statusACTIVE

NDC item 00832142515

NDC 90832-1425
NDC 100832-1425-15
NDC Item00832142515
packaging1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER
ANDAANDA215598
LabelerUpsher-Smith Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-12-15
Marketing statusACTIVE

NDC item 46708070605

NDC 946708-706
NDC 1046708-706-05
NDC Item46708070605
packaging1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER
ANDAANDA215230
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-08-25
Marketing statusACTIVE

NDC item 46708070610

NDC 946708-706
NDC 1046708-706-10
NDC Item46708070610
packaging1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER
ANDAANDA215230
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-08-25
Marketing statusACTIVE

NDC item 46708070615

NDC 946708-706
NDC 1046708-706-15
NDC Item46708070615
packaging1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER
ANDAANDA215230
LabelerAlembic Pharmaceuticals Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-08-25
Marketing statusACTIVE

NDC item 60219206703

NDC 960219-2067
NDC 1060219-2067-3
NDC Item60219206703
packaging1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE
ANDAANDA217288
LabelerAmneal Pharmaceuticals NY LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2025-01-02
Marketing statusACTIVE

NDC item 60219206806

NDC 960219-2068
NDC 1060219-2068-6
NDC Item60219206806
packaging1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE
ANDAANDA217288
LabelerAmneal Pharmaceuticals NY LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2025-01-02
Marketing statusACTIVE

NDC item 60219213808

NDC 960219-2138
NDC 1060219-2138-8
NDC Item60219213808
packaging1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE
ANDAANDA217288
LabelerAmneal Pharmaceuticals NY LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2025-01-02
Marketing statusACTIVE

NDC item 60505058901

NDC 960505-0589
NDC 1060505-0589-1
NDC Item60505058901
packaging1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER
ANDAANDA091442
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-10-19
Marketing statusACTIVE

NDC item 60505058902

NDC 960505-0589
NDC 1060505-0589-2
NDC Item60505058902
packaging1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER
ANDAANDA091442
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-10-19
Marketing statusACTIVE

NDC item 60505058903

NDC 960505-0589
NDC 1060505-0589-3
NDC Item60505058903
packaging1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER
ANDAANDA091442
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-10-19
Marketing statusACTIVE

NDC item 60505622500

NDC 960505-6225
NDC 1060505-6225-0
NDC Item60505622500
packaging1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA AUTHORIZED GENERIC
Marketing effective time high2024-12-31
Marketing effective time low2022-01-19
Marketing statusCOMPLETED
NDA_AUTHORIZED_GENERICNDA021398

NDC item 60505622501

NDC 960505-6225
NDC 1060505-6225-1
NDC Item60505622501
packaging1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA AUTHORIZED GENERIC
Marketing effective time high2024-12-31
Marketing effective time low2022-01-19
Marketing statusCOMPLETED
NDA_AUTHORIZED_GENERICNDA021398

NDC item 60505622502

NDC 960505-6225
NDC 1060505-6225-2
NDC Item60505622502
packaging1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA AUTHORIZED GENERIC
Marketing effective time high2024-12-31
Marketing effective time low2022-01-19
Marketing statusCOMPLETED
NDA_AUTHORIZED_GENERICNDA021398

NDC item 62332070605

NDC 962332-706
NDC 1062332-706-05
NDC Item62332070605
packaging1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER
ANDAANDA215230
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-08-25
Marketing statusACTIVE

NDC item 62332070610

NDC 962332-706
NDC 1062332-706-10
NDC Item62332070610
packaging1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER
ANDAANDA215230
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-08-25
Marketing statusACTIVE

NDC item 62332070615

NDC 962332-706
NDC 1062332-706-15
NDC Item62332070615
packaging1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER
ANDAANDA215230
LabelerAlembic Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-08-25
Marketing statusACTIVE

NDC item 65145016201

NDC 965145-162
NDC 1065145-162-01
NDC Item65145016201
packaging1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER
ANDAANDA219093
LabelerCaplin Steriles Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2025-03-10
Marketing statusACTIVE

NDC item 65145016301

NDC 965145-163
NDC 1065145-163-01
NDC Item65145016301
packaging1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER
ANDAANDA219093
LabelerCaplin Steriles Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2025-03-10
Marketing statusACTIVE

NDC item 65145016401

NDC 965145-164
NDC 1065145-164-01
NDC Item65145016401
packaging1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER
ANDAANDA219093
LabelerCaplin Steriles Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2025-03-10
Marketing statusACTIVE

NDC item 68462028132

NDC 968462-281
NDC 1068462-281-32
NDC Item68462028132
packaging1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER
ANDAANDA214987
LabelerGlenmark Pharmaceuticals Inc., USA
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-05-16
Marketing statusACTIVE

NDC item 68462028169

NDC 968462-281
NDC 1068462-281-69
NDC Item68462028169
packaging1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER
ANDAANDA214987
LabelerGlenmark Pharmaceuticals Inc., USA
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-05-16
Marketing statusACTIVE

NDC item 69315033005

NDC 969315-330
NDC 1069315-330-05
NDC Item69315033005
packaging1 BOTTLE, DROPPER in 1 CARTON (69315-330-05) / 5 mL in 1 BOTTLE, DROPPER
ANDAANDA219093
LabelerLeading Pharma, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2025-05-29
Marketing statusACTIVE

NDC item 69315033010

NDC 969315-330
NDC 1069315-330-10
NDC Item69315033010
packaging1 BOTTLE, DROPPER in 1 CARTON (69315-330-10) / 10 mL in 1 BOTTLE, DROPPER
ANDAANDA219093
LabelerLeading Pharma, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2025-05-29
Marketing statusACTIVE

NDC item 69315033015

NDC 969315-330
NDC 1069315-330-15
NDC Item69315033015
packaging1 BOTTLE, DROPPER in 1 CARTON (69315-330-15) / 15 mL in 1 BOTTLE, DROPPER
ANDAANDA219093
LabelerLeading Pharma, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2025-05-29
Marketing statusACTIVE

NDC item 70069065101

NDC 970069-651
NDC 1070069-651-01
NDC Item70069065101
packaging1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE
ANDAANDA216114
LabelerSomerset Therapeutics, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-10-10
Marketing statusACTIVE

NDC item 70069065201

NDC 970069-652
NDC 1070069-652-01
NDC Item70069065201
packaging1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE
ANDAANDA216114
LabelerSomerset Therapeutics, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-10-10
Marketing statusACTIVE

NDC item 70069065301

NDC 970069-653
NDC 1070069-653-01
NDC Item70069065301
packaging1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE
ANDAANDA216114
LabelerSomerset Therapeutics, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-10-10
Marketing statusACTIVE

NDC item 71921018805

NDC 971921-188
NDC 1071921-188-05
NDC Item71921018805
packaging1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER
ANDAANDA201949
LabelerFlorida Pharmaceutical Products, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-11-23
Marketing statusACTIVE

NDC item 71921018810

NDC 971921-188
NDC 1071921-188-10
NDC Item71921018810
packaging1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER
ANDAANDA201949
LabelerFlorida Pharmaceutical Products, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-11-23
Marketing statusACTIVE

NDC item 71921018815

NDC 971921-188
NDC 1071921-188-15
NDC Item71921018815
packaging1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER
ANDAANDA201949
LabelerFlorida Pharmaceutical Products, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-11-23
Marketing statusACTIVE

NDC item 72162209602

NDC 972162-2096
NDC 1072162-2096-2
NDC Item72162209602
packaging1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER
ANDAANDA091442
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-10-19
Marketing statusACTIVE

NDC item 72162209604

NDC 972162-2096
NDC 1072162-2096-4
NDC Item72162209604
packaging1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER
ANDAANDA091442
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-10-19
Marketing statusACTIVE

NDC item 72162209607

NDC 972162-2096
NDC 1072162-2096-7
NDC Item72162209607
packaging1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER
ANDAANDA091442
LabelerBryant Ranch Prepack
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-10-19
Marketing statusACTIVE

NDC item 72485063405

NDC 972485-634
NDC 1072485-634-05
NDC Item72485063405
packaging1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER
ANDAANDA201949
LabelerARMAS PHARMACEUTICALS INC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-11-03
Marketing statusACTIVE

NDC item 72485063410

NDC 972485-634
NDC 1072485-634-10
NDC Item72485063410
packaging1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER
ANDAANDA201949
LabelerARMAS PHARMACEUTICALS INC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-11-03
Marketing statusACTIVE

NDC item 82182045505

NDC 982182-455
NDC 1082182-455-05
NDC Item82182045505
packaging5 mL in 1 BOTTLE, PLASTIC (82182-455-05)
LabelerPacific Pharma, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA AUTHORIZED GENERIC
Marketing effective time low2022-10-21
Marketing statusACTIVE
NDA_AUTHORIZED_GENERICNDA021398

NDC item 82182045510

NDC 982182-455
NDC 1082182-455-10
NDC Item82182045510
packaging10 mL in 1 BOTTLE, PLASTIC (82182-455-10)
LabelerPacific Pharma, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA AUTHORIZED GENERIC
Marketing effective time low2022-10-21
Marketing statusACTIVE
NDA_AUTHORIZED_GENERICNDA021398

NDC item 82182045515

NDC 982182-455
NDC 1082182-455-15
NDC Item82182045515
packaging15 mL in 1 BOTTLE, PLASTIC (82182-455-15)
LabelerPacific Pharma, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA AUTHORIZED GENERIC
Marketing effective time low2022-10-21
Marketing statusACTIVE
NDA_AUTHORIZED_GENERICNDA021398