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NDC properties for NDC 9 0093-4085

NDC item 00093408563

NDC 90093-4085
NDC 100093-4085-63
NDC Item00093408563
packaging56 AMPULE in 1 CARTON (0093-4085-63) / 5 mL in 1 AMPULE
ANDAANDA091589
FDA SPL set id861925
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2013-11-19
Marketing statusACTIVE

NDC item 00781717156

NDC 90781-7171
NDC 100781-7171-56
NDC Item00781717156
packaging56 AMPULE in 1 CARTON (0781-7171-56) / 5 mL in 1 AMPULE (0781-7171-75)
FDA SPL set id132419
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA AUTHORIZED GENERIC
Marketing effective time low2014-07-09
Marketing statusCOMPLETED
NDA_AUTHORIZED_GENERICNDA050753

NDC item 00781717175

NDC 90781-7171
NDC 100781-7171-75
NDC Item00781717175
packaging5 mL in 1 AMPULE
FDA SPL set id132419
LabelerSandoz Inc
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA AUTHORIZED GENERIC
Marketing effective time low2014-07-09
Marketing statusCOMPLETED
NDA_AUTHORIZED_GENERICNDA050753

NDC item 16714011902

NDC 916714-119
NDC 1016714-119-02
NDC Item16714011902
packaging5 mL in 1 AMPULE
ANDAANDA207080
FDA SPL set id842222
LabelerNorthStar RxLLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2020-05-21
Marketing statusACTIVE

NDC item 16714011903

NDC 916714-119
NDC 1016714-119-03
NDC Item16714011903
packaging14 POUCH in 1 CARTON (16714-119-03) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE (16714-119-02)
ANDAANDA207080
FDA SPL set id842222
LabelerNorthStar RxLLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2020-05-21
Marketing statusACTIVE

NDC item 17478034038

NDC 917478-340
NDC 1017478-340-38
NDC Item17478034038
packaging14 POUCH in 1 CARTON (17478-340-38) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE
ANDAANDA201422
FDA SPL set id656792
LabelerAkorn Operating Company LLC (dba Akorn)
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing statusACTIVE

NDC item 42571040809

NDC 942571-408
NDC 1042571-408-09
NDC Item42571040809
packaging5 mL in 1 AMPULE
ANDAANDA217344
FDA SPL set id812408
LabelerMicro Labs Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-01-01
Marketing statusACTIVE

NDC item 42571040819

NDC 942571-408
NDC 1042571-408-19
NDC Item42571040819
packaging4 in 1 POUCH
ANDAANDA217344
FDA SPL set id812408
LabelerMicro Labs Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-01-01
Marketing statusACTIVE

NDC item 42571040892

NDC 942571-408
NDC 1042571-408-92
NDC Item42571040892
packaging14 POUCH in 1 CARTON (42571-408-92) / 4 AMPULE in 1 POUCH (42571-408-19) / 5 mL in 1 AMPULE (42571-408-09)
ANDAANDA217344
FDA SPL set id812408
LabelerMicro Labs Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-01-01
Marketing statusACTIVE

NDC item 43598060504

NDC 943598-605
NDC 1043598-605-04
NDC Item43598060504
ANDAANDA207080
FDA SPL set id706735
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2019-05-14
Marketing statusACTIVE

NDC item 43598060511

NDC 943598-605
NDC 1043598-605-11
NDC Item43598060511
ANDAANDA207080
FDA SPL set id706735
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2019-05-14
Marketing statusACTIVE

NDC item 43598060556

NDC 943598-605
NDC 1043598-605-56
NDC Item43598060556
packaging14 POUCH in 1 CARTON (43598-605-56) / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULE
ANDAANDA207080
FDA SPL set id706735
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2019-05-14
Marketing statusACTIVE

NDC item 43598060558

NDC 943598-605
NDC 1043598-605-58
NDC Item43598060558
packaging56 POUCH in 1 CARTON (43598-605-58) / 1 AMPULE in 1 POUCH (43598-605-11) / 5 mL in 1 AMPULE
ANDAANDA207080
FDA SPL set id706735
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2019-05-14
Marketing statusACTIVE

NDC item 47335017148

NDC 947335-171
NDC 1047335-171-48
NDC Item47335017148
packaging4 in 1 POUCH
packaging5 mL in 1 AMPULE
ANDAANDA207136
COLORTEXTYELLOW(Colourless to light yellow)
ColorC48330 __
FDA SPL set id707885
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2020-02-28
Marketing statusACTIVE

NDC item 47335017149

NDC 947335-171
NDC 1047335-171-49
NDC Item47335017149
packaging14 POUCH in 1 CARTON (47335-171-49) / 4 AMPULE in 1 POUCH (47335-171-48) / 5 mL in 1 AMPULE
ANDAANDA207136
COLORTEXTYELLOW(Colourless to light yellow)
ColorC48330 __
FDA SPL set id707885
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2020-02-28
Marketing statusACTIVE

NDC item 59651012904

NDC 959651-129
NDC 1059651-129-04
NDC Item59651012904
packaging4 in 1 POUCH
packaging5 mL in 1 AMPULE
ANDAANDA210871
FDA SPL set id710977
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-22
Marketing statusACTIVE

NDC item 59651012956

NDC 959651-129
NDC 1059651-129-56
NDC Item59651012956
packaging14 POUCH in 1 CARTON (59651-129-56) / 4 AMPULE in 1 POUCH (59651-129-04) / 5 mL in 1 AMPULE
ANDAANDA210871
FDA SPL set id710977
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-01-22
Marketing statusACTIVE

NDC item 60687073179

NDC 960687-731
NDC 1060687-731-79
NDC Item60687073179
packaging1 in 1 POUCH
packaging5 mL in 1 AMPULE
ANDAANDA207136
COLORTEXTyellow(Colourless to light yellow)
ColorC48330 __
FDA SPL set id786945
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-05-19
Marketing statusACTIVE

NDC item 60687073183

NDC 960687-731
NDC 1060687-731-83
NDC Item60687073183
packaging30 POUCH in 1 CARTON (60687-731-83) / 1 AMPULE in 1 POUCH (60687-731-79) / 5 mL in 1 AMPULE
ANDAANDA207136
COLORTEXTyellow(Colourless to light yellow)
ColorC48330 __
FDA SPL set id786945
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-05-19
Marketing statusACTIVE

NDC item 65162091446

NDC 965162-914
NDC 1065162-914-46
NDC Item65162091446
packaging56 AMPULE in 1 CARTON (65162-914-46) / 5 mL in 1 AMPULE
ANDAANDA205501
COLORTEXTyellow(clear, slightly yellow)
ColorC48330 __
FDA SPL set id824547
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-07-13
Marketing statusACTIVE

NDC item 67877067869

NDC 967877-678
NDC 1067877-678-69
NDC Item67877067869
packaging5 mL in 1 AMPULE
packaging7 in 1 POUCH
ANDAANDA212848
FDA SPL set id762146
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-04-02
Marketing statusACTIVE

NDC item 67877067870

NDC 967877-678
NDC 1067877-678-70
NDC Item67877067870
packaging56 POUCH in 1 CARTON (67877-678-70) / 7 AMPULE in 1 POUCH (67877-678-69) / 5 mL in 1 AMPULE
ANDAANDA212848
FDA SPL set id762146
LabelerAscend Laboratories, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2021-04-02
Marketing statusACTIVE

NDC item 68180096204

NDC 968180-962
NDC 1068180-962-04
NDC Item68180096204
packaging4 in 1 POUCH
packaging5 mL in 1 AMPULE
ANDAANDA208964
FDA SPL set id779846
LabelerLupin Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-06-12
Marketing statusACTIVE

NDC item 68180096256

NDC 968180-962
NDC 1068180-962-56
NDC Item68180096256
packaging56 POUCH in 1 CARTON (68180-962-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE
ANDAANDA208964
FDA SPL set id779846
LabelerLupin Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2018-06-12
Marketing statusACTIVE

NDC item 70644089999

NDC 970644-899
NDC 1070644-899-99
NDC Item70644089999
packaging14 POUCH in 1 CARTON (70644-899-99) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE
FDA SPL set id849478
LabelerGenericus, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA AUTHORIZED GENERIC
Marketing effective time low2016-07-11
Marketing statusACTIVE
NDA_AUTHORIZED_GENERICNDA205433

NDC item 70756060444

NDC 970756-604
NDC 1070756-604-44
NDC Item70756060444
packaging4 in 1 POUCH
packaging5 mL in 1 AMPULE
ANDAANDA214478
FDA SPL set id805293
LabelerLifestar Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-06-30
Marketing statusACTIVE

NDC item 70756060456

NDC 970756-604
NDC 1070756-604-56
NDC Item70756060456
packaging14 POUCH in 1 CARTON (70756-604-56) / 4 AMPULE in 1 POUCH (70756-604-44) / 5 mL in 1 AMPULE
ANDAANDA214478
FDA SPL set id805293
LabelerLifestar Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-06-30
Marketing statusACTIVE

NDC item 72603043004

NDC 972603-430
NDC 1072603-430-04
NDC Item72603043004
packaging4 in 1 POUCH
packaging5 mL in 1 AMPULE
ANDAANDA214478
FDA SPL set id801097
LabelerNorthStar RxLLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-08-01
Marketing statusACTIVE

NDC item 72603043056

NDC 972603-430
NDC 1072603-430-56
NDC Item72603043056
packaging14 POUCH in 1 CARTON (72603-430-56) / 4 AMPULE in 1 POUCH (72603-430-04) / 5 mL in 1 AMPULE
ANDAANDA214478
FDA SPL set id801097
LabelerNorthStar RxLLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-08-01
Marketing statusACTIVE

NDC item 76204002956

NDC 976204-029
NDC 1076204-029-56
NDC Item76204002956
packaging14 POUCH in 1 CARTON (76204-029-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE
ANDAANDA201422
FDA SPL set id866956
LabelerRitedose Pharmaceuticals, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2025-03-25
Marketing statusactive