PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride Injection, USP
Approved
Approval ID
b6f6698f-f23c-452a-9b38-bbb96ab88ae4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
XGen Pharmaceuticals DJB, Inc.
DUNS: 117380305
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 Code39822-5550
Application NumberANDA040737
Product Classification
M
Marketing Category
C73584
G
Generic Name
PROMETHAZINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (8)
CALCIUM CHLORIDEInactive
Quantity: 0.01 mg in 1 mL
Code: M4I0D6VV5M
Classification: IACT
SODIUM METABISULFITEInactive
Quantity: 0.25 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
EDETATE SODIUMInactive
Quantity: 0.1 mg in 1 mL
Code: MP1J8420LU
Classification: IACT
PHENOLInactive
Quantity: 5 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
PROMETHAZINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 mL
Code: R61ZEH7I1I
Classification: ACTIB