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Omeprazole and Sodium Bicarbonate

These highlights do not include all the information needed to use OMEPRAZOLE AND SODIUM BICARBONATE safely and effectively. See full prescribing information for OMEPRAZOLE AND SODIUM BICARBONATE. OMEPRAZOLE AND SODIUM BICARBONATE for oral suspension OMEPRAZOLE AND SODIUM BICARBONATE capsules, for oral use Initial U.S. Approval: 2004

Approved
Approval ID

c26b6893-8264-4d4a-ac7e-1ddda933451e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 11, 2023

Manufacturers
FDA

Oceanside Pharmaceuticals

DUNS: 832011691

Products 4

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 Code68682-104
Application NumberNDA021849
Product Classification
M
Marketing Category
C73605
G
Generic Name
omeprazole, sodium bicarbonate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 11, 2023
FDA Product Classification

INGREDIENTS (4)

SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
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

omeprazole, sodium bicarbonate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68682-102
Application NumberNDA021849
Product Classification
M
Marketing Category
C73605
G
Generic Name
omeprazole, sodium bicarbonate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 11, 2023
FDA Product Classification

INGREDIENTS (4)

CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
SODIUM BICARBONATEActive
Quantity: 1100 mg in 1 1
Code: 8MDF5V39QO
Classification: ACTIB
OMEPRAZOLEActive
Quantity: 20 mg in 1 1
Code: KG60484QX9
Classification: ACTIB

omeprazole, sodium bicarbonate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68682-990
Application NumberNDA021636
Product Classification
M
Marketing Category
C73605
G
Generic Name
omeprazole, sodium bicarbonate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 11, 2023
FDA Product Classification

INGREDIENTS (6)

XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SODIUM BICARBONATEActive
Quantity: 1680 mg in 1 1
Code: 8MDF5V39QO
Classification: ACTIB
OMEPRAZOLEActive
Quantity: 20 mg in 1 1
Code: KG60484QX9
Classification: ACTIB

omeprazole, sodium bicarbonate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68682-991
Application NumberNDA021636
Product Classification
M
Marketing Category
C73605
G
Generic Name
omeprazole, sodium bicarbonate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 11, 2023
FDA Product Classification

INGREDIENTS (6)

XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
OMEPRAZOLEActive
Quantity: 40 mg in 1 1
Code: KG60484QX9
Classification: ACTIB
SODIUM BICARBONATEActive
Quantity: 1680 mg in 1 1
Code: 8MDF5V39QO
Classification: ACTIB

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