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ZEGERID

These highlights do not include all the information needed to use ZEGERID safely and effectively. See full prescribing information for ZEGERID.ZEGERID (omeprazole and sodium bicarbonate) for oral suspensionZEGERID (omeprazole and sodium bicarbonate) capsules, for oral useInitial U.S. Approval: 2004

Approved
Approval ID

cd6868b9-5824-442b-8d65-4db29ecb70a4

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 19, 2023

Manufacturers
FDA

Santarus, Inc..

DUNS: 104286369

Products 4

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 Code68012-104
Application NumberNDA021849
Product Classification
M
Marketing Category
C73594
G
Generic Name
omeprazole and sodium bicarbonate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 19, 2023
FDA Product Classification

INGREDIENTS (4)

OMEPRAZOLEActive
Quantity: 40 mg in 1 1
Code: KG60484QX9
Classification: ACTIB
SODIUM BICARBONATEActive
Quantity: 1100 mg in 1 1
Code: 8MDF5V39QO
Classification: ACTIB
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT

omeprazole and sodium bicarbonate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68012-102
Application NumberNDA021849
Product Classification
M
Marketing Category
C73594
G
Generic Name
omeprazole and sodium bicarbonate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 19, 2023
FDA Product Classification

INGREDIENTS (4)

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

omeprazole and sodium bicarbonate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68012-054
Application NumberNDA021636
Product Classification
M
Marketing Category
C73594
G
Generic Name
omeprazole and sodium bicarbonate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 19, 2023
FDA Product Classification

INGREDIENTS (6)

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

omeprazole and sodium bicarbonate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68012-052
Application NumberNDA021636
Product Classification
M
Marketing Category
C73594
G
Generic Name
omeprazole and sodium bicarbonate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 19, 2023
FDA Product Classification

INGREDIENTS (6)

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

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ZEGERID - FDA Drug Approval Details