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.
promethazine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0713-0132
Application NumberANDA087165
Product Classification
M
Marketing Category
C73584
G
Generic Name
promethazine hydrochloride
Product Specifications
Route of AdministrationRECTAL
Effective DateNovember 30, 2023
FDA Product Classification
INGREDIENTS (4)
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