PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride Injection, USP Rx Only
Approved
Approval ID
6288f74d-d69c-421a-8eab-eb7e19e6075e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 2022
Manufacturers
FDA
General Injectables and 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 Code52584-078
Application NumberANDA083312
Product Classification
M
Marketing Category
C73584
G
Generic Name
PROMETHAZINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateDecember 29, 2022
FDA Product Classification
INGREDIENTS (8)
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
EDETATE DISODIUMInactive
Quantity: 0.1 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
PHENOLInactive
Quantity: 5 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
SODIUM METABISULFITEInactive
Quantity: .25 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT