PROMETHEGAN

PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES, USP Rx Only

Approved

Approval ID

636bb9bc-0cc5-4d6a-85be-6471acf01ffc

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 30, 2023

Manufacturers

FDA

Cosette Pharmaceuticals, Inc.

DUNS: 116918230

Products 1

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

NDC Product Code0713-0132

Application NumberANDA087165

Marketing CategoryC73584

Route of AdministrationRECTAL

Effective DateNovember 30, 2023

Generic Namepromethazine hydrochloride

ASCORBYL PALMITATEInactive

Code: QN83US2B0N

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

HARD FATInactive

Code: 8334LX7S21

Classification: IACT

PROMETHAZINE HYDROCHLORIDEActive

Quantity: 50 mg in 1 1

Code: R61ZEH7I1I

Classification: ACTIB