Omeprazole and Sodium Bicarbonate

Manufacturing Establishments1

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

ScieGen Pharmaceuticals, Inc.

Labeler

ScieGen Pharmaceuticals, Inc.

DUNS Number

079391286

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Product Details

NDC Product Code

50228-363

Application Number

ANDA207476

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 6, 2023

Ingredients

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

OmeprazoleActive

Code: KG60484QX9Class: ACTIBQuantity: 20 mg in 1 1

Sodium bicarbonateActive

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

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SODIUM STEARYL FUMARATEInactive

Code: 7CV7WJK4UIClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT