Promethazine
Promethazine Hydrochloride Injection, USP
Approved
Approval ID
501b3b8f-dabb-47d9-bb09-09b4ffd0fb46
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 9, 2009
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-0262
Application NumberANDA040454
Product Classification
M
Marketing Category
C73584
G
Generic Name
promethazine hydrochloride
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateAugust 16, 2011
FDA Product Classification
INGREDIENTS (7)
sodium metabisulfiteInactive
Code: 4VON5FNS3C
Classification: IACT
phenolInactive
Code: 339NCG44TV
Classification: IACT
promethazine hydrochlorideActive
Quantity: 50 mg in 1 mL
Code: R61ZEH7I1I
Classification: ACTIB
calcium chlorideInactive
Code: M4I0D6VV5M
Classification: IACT
edetate disodiumInactive
Code: 7FLD91C86K
Classification: IACT
acetic acidInactive
Code: Q40Q9N063P
Classification: IACT
sodium acetateInactive
Code: 4550K0SC9B
Classification: IACT