Promethazine Hydrochloride
Promethazine Hydrochloride Injection, USPRx only
Approved
Approval ID
8028f8a5-606d-4e5c-aa55-68184d09c17e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 15, 2011
Manufacturers
FDA
West-ward Pharmaceutical Corp.
DUNS: 946499746
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 Code0641-6099
Application NumberANDA083312
Product Classification
M
Marketing Category
C73584
G
Generic Name
Promethazine Hydrochloride
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateSeptember 15, 2011
FDA Product Classification
INGREDIENTS (8)
EDETATE DISODIUMInactive
Quantity: 0.1 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
CALCIUM CHLORIDEInactive
Quantity: 0.04 mg in 1 mL
Code: M4I0D6VV5M
Classification: IACT
PROMETHAZINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 mL
Code: R61ZEH7I1I
Classification: ACTIB
SODIUM METABISULFITEInactive
Quantity: 0.25 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
PHENOLInactive
Quantity: 5 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT