omeprazole and sodium bicarbonate

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Zydus Pharmaceuticals USA Inc.

DUNS Number

156861945

Manufacturing Establishments1

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

Zydus Lifesciences Limited

Labeler

Zydus Pharmaceuticals USA Inc.

Registrant

Zydus Pharmaceuticals USA Inc.

DUNS Number

918596198

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

68382-502

Application Number

ANDA203290

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 24, 2023

Ingredients

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SODIUM STEARYL FUMARATEInactive

Code: 7CV7WJK4UIClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

OmeprazoleActive

Code: KG60484QX9Class: ACTIBQuantity: 40 mg in 1 1

Sodium bicarbonateActive

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