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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

Oceanside Pharmaceuticals

DUNS: 832011691

Effective Date

October 11, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Omeprazole(40 mg in 1 1)

Sodium bicarbonate(1100 mg in 1 1)

Manufacturing Establishments4

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Norwich Pharmaceuticals, Inc

Labeler

Oceanside Pharmaceuticals

DUNS Number

132218731

Bausch Health Companies, Inc.

Labeler

Oceanside Pharmaceuticals

DUNS Number

253292734

PTI Royston LLC

Labeler

Oceanside Pharmaceuticals

DUNS Number

601006997

Labeler

Oceanside Pharmaceuticals

DUNS Number

205475333

Products4

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

68682-104

Application Number

NDA021849

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

October 11, 2023

Ingredients

SODIUM STEARYL FUMARATEInactive

Code: 7CV7WJK4UIClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

OmeprazoleActive

Code: KG60484QX9Class: ACTIBQuantity: 40 mg in 1 1

Sodium bicarbonateActive

Code: 8MDF5V39QOClass: ACTIBQuantity: 1100 mg in 1 1

Omeprazole and Sodium Bicarbonate

Product Details

NDC Product Code

68682-102

Application Number

NDA021849

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

October 11, 2023

Ingredients

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

SODIUM STEARYL FUMARATEInactive

Code: 7CV7WJK4UIClass: IACT

Sodium bicarbonateActive

Code: 8MDF5V39QOClass: ACTIBQuantity: 1100 mg in 1 1

OmeprazoleActive

Code: KG60484QX9Class: ACTIBQuantity: 20 mg in 1 1

Omeprazole and Sodium Bicarbonate

Product Details

NDC Product Code

68682-990

Application Number

NDA021636

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

October 11, 2023

Ingredients

XYLITOLInactive

Code: VCQ006KQ1EClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

SUCRALOSEInactive

Code: 96K6UQ3ZD4Class: IACT

XANTHAN GUMInactive

Code: TTV12P4NEEClass: IACT

Sodium bicarbonateActive

Code: 8MDF5V39QOClass: ACTIBQuantity: 1680 mg in 1 1

OmeprazoleActive

Code: KG60484QX9Class: ACTIBQuantity: 20 mg in 1 1

Omeprazole and Sodium Bicarbonate

Product Details

NDC Product Code

68682-991

Application Number

NDA021636

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

October 11, 2023

Ingredients

XYLITOLInactive

Code: VCQ006KQ1EClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

SUCRALOSEInactive

Code: 96K6UQ3ZD4Class: IACT

XANTHAN GUMInactive

Code: TTV12P4NEEClass: IACT

OmeprazoleActive

Code: KG60484QX9Class: ACTIBQuantity: 40 mg in 1 1

Sodium bicarbonateActive

Code: 8MDF5V39QOClass: ACTIBQuantity: 1680 mg in 1 1

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