Omeprazole, 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
5cb3b887-919f-4c47-aa07-eb10182dfcc3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 8, 2021
Manufacturers
FDA
Woodward Pharma Services LLC
DUNS: 080406260
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Omeprazole, Sodium bicarbonate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69784-701
Application NumberANDA212587
Product Classification
M
Marketing Category
C73584
G
Generic Name
Omeprazole, Sodium bicarbonate
Product Specifications
Route of AdministrationORAL
Effective DateJune 8, 2021
FDA Product Classification
INGREDIENTS (10)
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
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
Omeprazole, Sodium bicarbonate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69784-700
Application NumberANDA212587
Product Classification
M
Marketing Category
C73584
G
Generic Name
Omeprazole, Sodium bicarbonate
Product Specifications
Route of AdministrationORAL
Effective DateJune 8, 2021
FDA Product Classification
INGREDIENTS (13)
OMEPRAZOLEActive
Quantity: 40 mg in 1 1
Code: KG60484QX9
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM BICARBONATEActive
Quantity: 1100 mg in 1 1
Code: 8MDF5V39QO
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT