Promethazine Hydrochloride
Promethazine Hydrochloride
Approved
Approval ID
7834998b-2c53-4edc-97d9-508f7cc92f7c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 22, 2023
Manufacturers
FDA
Marlex Pharmaceuticals Inc
DUNS: 782540215
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 Code10135-495
Application NumberANDA091179
Product Classification
M
Marketing Category
C73584
G
Generic Name
promethazine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 22, 2023
FDA Product Classification
INGREDIENTS (4)
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PROMETHAZINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: R61ZEH7I1I
Classification: ACTIB