Promethazine Hydrochloride
Promethazine HCL 50 mg/mL Injection, USP 1 mL Single Dose Ampule
Approved
Approval ID
bf597543-c480-4835-abcc-aa3ab83e8b8b
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 Code52584-496
Application NumberANDA083312
Product Classification
M
Marketing Category
C73584
G
Generic Name
Promethazine Hydrochloride
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateDecember 29, 2022
FDA Product Classification
INGREDIENTS (1)
Promethazine HydrochlorideActive
Quantity: 50 mg in 1 mL
Code: R61ZEH7I1I
Classification: ACTIB