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FDA Approval

Omeprazole and Sodium Bicarbonate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Ajanta Pharma USA Inc.
DUNS: 557554156
Effective Date
November 20, 2023
Labeling Type
Human Prescription Drug Label
Omeprazole(20 mg in 1 1)
Sodium bicarbonate(1100 mg in 1 1)

Products2

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

NDC Product Code
27241-031
Application Number
ANDA204228
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
November 23, 2023
OmeprazoleActive
Code: KG60484QX9Class: ACTIBQuantity: 20 mg in 1 1
Sodium bicarbonateActive
Code: 8MDF5V39QOClass: ACTIBQuantity: 1100 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT

Omeprazole and Sodium Bicarbonate

Product Details

NDC Product Code
27241-032
Application Number
ANDA204228
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
November 23, 2023
OmeprazoleActive
Code: KG60484QX9Class: ACTIBQuantity: 40 mg in 1 1
Sodium bicarbonateActive
Code: 8MDF5V39QOClass: ACTIBQuantity: 1100 mg in 1 1
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
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