Promethazine Hydrochloride
Promethazine HCL 25 mg/mL Injection, USP 1 mL Single Dose Ampule
Approved
Approval ID
36c9c162-90af-4f7b-9f56-5d81ed850dbe
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 2022
Manufacturers
FDA
General Injectables & Vaccines, Inc
DUNS: 108250663
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 Code52584-495
Application NumberANDA083312
Product Classification
M
Marketing Category
C73584
G
Generic Name
Promethazine Hydrochloride
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJanuary 5, 2023
FDA Product Classification
INGREDIENTS (1)
Promethazine HydrochlorideActive
Quantity: 25 mg in 1 mL
Code: R61ZEH7I1I
Classification: ACTIB