Omeprazole and Sodium Bicarbonate
These highlights do not include all the information needed to use OMEPRAZOLE AND SODIUM BICARBONATE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE AND SODIUM BICARBONATE CAPSULES. OMEPRAZOLE and SODIUM BICARBONATE capsules, for oral use Initial U.S. Approval: 2004
Approved
Approval ID
a107804e-b308-4e79-9447-07d93016f70f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 6, 2023
Manufacturers
FDA
ScieGen Pharmaceuticals, Inc.
DUNS: 079391286
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Omeprazole and Sodium Bicarbonate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50228-363
Application NumberANDA207476
Product Classification
M
Marketing Category
C73584
G
Generic Name
Omeprazole and Sodium Bicarbonate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 6, 2023
FDA Product Classification
INGREDIENTS (15)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
OMEPRAZOLEActive
Quantity: 20 mg in 1 1
Code: KG60484QX9
Classification: ACTIB
SODIUM BICARBONATEActive
Quantity: 1100 mg in 1 1
Code: 8MDF5V39QO
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
Omeprazole and Sodium Bicarbonate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50228-364
Application NumberANDA207476
Product Classification
M
Marketing Category
C73584
G
Generic Name
Omeprazole and Sodium Bicarbonate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 6, 2023
FDA Product Classification
INGREDIENTS (15)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
OMEPRAZOLEActive
Quantity: 40 mg in 1 1
Code: KG60484QX9
Classification: ACTIB
SODIUM BICARBONATEActive
Quantity: 1100 mg in 1 1
Code: 8MDF5V39QO
Classification: ACTIB
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT