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NDC properties for NDC 9 16571-141

NDC item 16571014110

NDC 916571-141
NDC 1016571-141-10
NDC Item16571014110
packaging1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE
ANDAANDA077259
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing statusCOMPLETED

NDC item 16571014115

NDC 916571-141
NDC 1016571-141-15
NDC Item16571014115
packaging1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE
ANDAANDA077259
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing statusCOMPLETED

NDC item 16571014150

NDC 916571-141
NDC 1016571-141-50
NDC Item16571014150
packaging1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE
ANDAANDA077259
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing statusCOMPLETED

NDC item 17478028810

NDC 917478-288
NDC 1017478-288-10
NDC Item17478028810
packaging1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER
ANDAANDA074466
FDA SPL set id639625
LabelerAkorn Operating Company LLC (dba Akorn)
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-03-26
Marketing statusACTIVE

NDC item 17478028811

NDC 917478-288
NDC 1017478-288-11
NDC Item17478028811
packaging1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER
ANDAANDA074466
FDA SPL set id639625
LabelerAkorn Operating Company LLC (dba Akorn)
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-03-26
Marketing statusACTIVE

NDC item 17478028812

NDC 917478-288
NDC 1017478-288-12
NDC Item17478028812
packaging1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER
ANDAANDA074466
FDA SPL set id639625
LabelerAkorn Operating Company LLC (dba Akorn)
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-03-26
Marketing statusACTIVE

NDC item 42571040421

NDC 942571-404
NDC 1042571-404-21
NDC Item42571040421
packaging5 mL in 1 BOTTLE (42571-404-21)
ANDAANDA217343
FDA SPL set id813651
LabelerMicro Labs Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-08-01
Marketing statusACTIVE

NDC item 42571040488

NDC 942571-404
NDC 1042571-404-88
NDC Item42571040488
packaging10 mL in 1 BOTTLE (42571-404-88)
ANDAANDA217343
FDA SPL set id813651
LabelerMicro Labs Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-08-01
Marketing statusACTIVE

NDC item 50090185200

NDC 950090-1852
NDC 1050090-1852-0
NDC Item50090185200
packaging1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE
ANDAANDA077259
FDA SPL set id717511
LabelerA-S Medication Solutions
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-12-15
Marketing statusACTIVE

NDC item 50090344100

NDC 950090-3441
NDC 1050090-3441-0
NDC Item50090344100
packaging10 mL in 1 BOTTLE, PLASTIC (50090-3441-0)
ANDAANDA074262
FDA SPL set id844230
LabelerA-S Medication Solutions
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1996-01-15
Marketing statusACTIVE

NDC item 50090509100

NDC 950090-5091
NDC 1050090-5091-0
NDC Item50090509100
packaging1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE
ANDAANDA077259
FDA SPL set id501115
LabelerA-S Medication Solutions LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-12-15
Marketing statusACTIVE

NDC item 50090576900

NDC 950090-5769
NDC 1050090-5769-0
NDC Item50090576900
packaging1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER
ANDAANDA074747
COLORTEXTwhite(clear/ light yellow)
ColorC48325 __
FDA SPL set id789204
LabelerA-S Medication Solutions
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1997-05-20
Marketing statusACTIVE

NDC item 55545100101

NDC 955545-1001
NDC 1055545-1001-1
NDC Item55545100101
packaging1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE
ANDAANDA077259
APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACTANDA077259
FDA SPL set id281769
LabelerFDC Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryAPPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT
Marketing effective time low2014-12-15
Marketing statusACTIVE

NDC item 55545100102

NDC 955545-1001
NDC 1055545-1001-2
NDC Item55545100102
packaging1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE
ANDAANDA077259
APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACTANDA077259
FDA SPL set id281769
LabelerFDC Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryAPPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT
Marketing effective time low2014-12-15
Marketing statusACTIVE

NDC item 55545100103

NDC 955545-1001
NDC 1055545-1001-3
NDC Item55545100103
packaging1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE
ANDAANDA077259
APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACTANDA077259
FDA SPL set id281769
LabelerFDC Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryAPPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT
Marketing effective time low2014-12-15
Marketing statusACTIVE

NDC item 60758080105

NDC 960758-801
NDC 1060758-801-05
NDC Item60758080105
packaging1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER
ANDAANDA074747
COLORTEXTwhite(clear/ light yellow)
ColorC48325 __
FDA SPL set id600609
LabelerPacific Pharma, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1997-05-20
Marketing statusACTIVE

NDC item 60758080110

NDC 960758-801
NDC 1060758-801-10
NDC Item60758080110
packaging1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER
ANDAANDA074747
COLORTEXTwhite(clear/ light yellow)
ColorC48325 __
FDA SPL set id600609
LabelerPacific Pharma, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1997-05-20
Marketing statusACTIVE

NDC item 61314022705

NDC 961314-227
NDC 1061314-227-05
NDC Item61314022705
packaging5 mL in 1 BOTTLE, PLASTIC (61314-227-05)
ANDAANDA074262
FDA SPL set id804173
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1996-01-15
Marketing statusACTIVE

NDC item 61314022710

NDC 961314-227
NDC 1061314-227-10
NDC Item61314022710
packaging10 mL in 1 BOTTLE, PLASTIC (61314-227-10)
ANDAANDA074262
FDA SPL set id804173
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1996-01-15
Marketing statusACTIVE

NDC item 61314022715

NDC 961314-227
NDC 1061314-227-15
NDC Item61314022715
packaging15 mL in 1 BOTTLE, PLASTIC (61314-227-15)
ANDAANDA074262
FDA SPL set id804173
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1996-01-15
Marketing statusACTIVE

NDC item 64980051401

NDC 964980-514
NDC 1064980-514-01
NDC Item64980051401
packaging1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE
ANDAANDA077259
FDA SPL set id804336
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-12-15
Marketing statusACTIVE

NDC item 64980051405

NDC 964980-514
NDC 1064980-514-05
NDC Item64980051405
packaging1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE
ANDAANDA077259
FDA SPL set id804336
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-12-15
Marketing statusACTIVE

NDC item 64980051415

NDC 964980-514
NDC 1064980-514-15
NDC Item64980051415
packaging1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE
ANDAANDA077259
FDA SPL set id804336
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-12-15
Marketing statusACTIVE

NDC item 65145015201

NDC 965145-152
NDC 1065145-152-01
NDC Item65145015201
packaging1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE
ANDAANDA218460
FDA SPL set id809977
LabelerCaplin Steriles Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-09-16
Marketing statusACTIVE

NDC item 65145015301

NDC 965145-153
NDC 1065145-153-01
NDC Item65145015301
packaging1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE
ANDAANDA218460
FDA SPL set id809977
LabelerCaplin Steriles Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-09-16
Marketing statusACTIVE

NDC item 65145015401

NDC 965145-154
NDC 1065145-154-01
NDC Item65145015401
packaging1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE
ANDAANDA218460
FDA SPL set id809977
LabelerCaplin Steriles Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-09-16
Marketing statusACTIVE

NDC item 68682081305

NDC 968682-813
NDC 1068682-813-05
NDC Item68682081305
packaging1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING
FDA SPL set id657377
LabelerOceanside Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA AUTHORIZED GENERIC
Marketing effective time low2020-06-01
Marketing statusACTIVE
NDA_AUTHORIZED_GENERICNDA018086

NDC item 68682081310

NDC 968682-813
NDC 1068682-813-10
NDC Item68682081310
packaging1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING
FDA SPL set id657377
LabelerOceanside Pharmaceuticals
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA AUTHORIZED GENERIC
Marketing effective time low2020-06-01
Marketing statusACTIVE
NDA_AUTHORIZED_GENERICNDA018086

NDC item 69315032505

NDC 969315-325
NDC 1069315-325-05
NDC Item69315032505
packaging5 mL in 1 BOTTLE, PLASTIC (69315-325-05)
ANDAANDA218460
COLORTEXTyellow(colorless to light yellow solution)
ColorC48330 __
FDA SPL set id828008
LabelerLeading Pharma, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-11-07
Marketing statusACTIVE

NDC item 69315032510

NDC 969315-325
NDC 1069315-325-10
NDC Item69315032510
packaging10 mL in 1 BOTTLE, PLASTIC (69315-325-10)
ANDAANDA218460
COLORTEXTyellow(colorless to light yellow solution)
ColorC48330 __
FDA SPL set id828008
LabelerLeading Pharma, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-11-07
Marketing statusACTIVE

NDC item 69315032515

NDC 969315-325
NDC 1069315-325-15
NDC Item69315032515
packaging15 mL in 1 BOTTLE, PLASTIC (69315-325-15)
ANDAANDA218460
COLORTEXTyellow(colorless to light yellow solution)
ColorC48330 __
FDA SPL set id828008
LabelerLeading Pharma, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-11-07
Marketing statusACTIVE

NDC item 70069070601

NDC 970069-706
NDC 1070069-706-01
NDC Item70069070601
packaging1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE
ANDAANDA217764
FDA SPL set id795204
LabelerSomerset Therapeutics, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-07-04
Marketing statusACTIVE

NDC item 70069070701

NDC 970069-707
NDC 1070069-707-01
NDC Item70069070701
packaging1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE
ANDAANDA217764
FDA SPL set id795204
LabelerSomerset Therapeutics, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-07-04
Marketing statusACTIVE

NDC item 70069070801

NDC 970069-708
NDC 1070069-708-01
NDC Item70069070801
packaging1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE
ANDAANDA217764
FDA SPL set id795204
LabelerSomerset Therapeutics, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-07-04
Marketing statusACTIVE

NDC item 70756065615

NDC 970756-656
NDC 1070756-656-15
NDC Item70756065615
packaging1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER
ANDAANDA078771
FDA SPL set id717503
LabelerLifestar Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-06-26
Marketing statusACTIVE

NDC item 70756065730

NDC 970756-657
NDC 1070756-657-30
NDC Item70756065730
packaging1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER
ANDAANDA078771
FDA SPL set id717503
LabelerLifestar Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-06-26
Marketing statusACTIVE

NDC item 72603054001

NDC 972603-540
NDC 1072603-540-01
NDC Item72603054001
packaging1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER
ANDAANDA078771
FDA SPL set id835679
LabelerNorthStar RxLLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-12-01
Marketing statusACTIVE

NDC item 76519116300

NDC 976519-1163
NDC 1076519-1163-0
NDC Item76519116300
packaging5 mL in 1 BOTTLE (76519-1163-0)
ANDAANDA077259
LabelerH.J. Harkins Co, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing statusACTIVE

NDC item 81469021005

NDC 981469-210
NDC 1081469-210-05
NDC Item81469021005
packaging1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER
ANDAANDA078771
FDA SPL set id785224
LabelerFirst Nation Group, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-05-10
Marketing statusACTIVE

NDC item 81469021010

NDC 981469-210
NDC 1081469-210-10
NDC Item81469021010
packaging1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER
ANDAANDA078771
FDA SPL set id785224
LabelerFirst Nation Group, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-05-10
Marketing statusACTIVE

NDC item 82260081305

NDC 982260-813
NDC 1082260-813-05
NDC Item82260081305
packaging1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING
FDA SPL set id863431
LabelerBausch & Lomb Americas Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA AUTHORIZED GENERIC
Marketing effective time low2020-06-01
Marketing statusACTIVE
NDA_AUTHORIZED_GENERICNDA018086

NDC item 82260081310

NDC 982260-813
NDC 1082260-813-10
NDC Item82260081310
packaging1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING
FDA SPL set id863431
LabelerBausch & Lomb Americas Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA AUTHORIZED GENERIC
Marketing effective time low2020-06-01
Marketing statusACTIVE
NDA_AUTHORIZED_GENERICNDA018086