Promethazine Hydrochloride
Promethazine Hydrochloride Injection, USP Rx onlyNOVAPLUS®
Approved
Approval ID
365138a6-28d8-4881-a3e9-02c80aaf83e8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 22, 2022
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 946499746
Products 2
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 Code0641-0956
Application NumberANDA083312
Product Classification
M
Marketing Category
C73584
G
Generic Name
Promethazine Hydrochloride
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateApril 22, 2022
FDA Product Classification
INGREDIENTS (8)
PROMETHAZINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 mL
Code: R61ZEH7I1I
Classification: ACTIB
EDETATE DISODIUMInactive
Quantity: 0.1 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
CALCIUM CHLORIDEInactive
Quantity: 0.04 mg in 1 mL
Code: M4I0D6VV5M
Classification: IACT
SODIUM METABISULFITEInactive
Quantity: 0.25 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
PHENOLInactive
Quantity: 5 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
Promethazine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0641-0955
Application NumberANDA083312
Product Classification
M
Marketing Category
C73584
G
Generic Name
Promethazine Hydrochloride
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateApril 22, 2022
FDA Product Classification
INGREDIENTS (8)
SODIUM ACETATEInactive
Code: 4550K0SC9B
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
CALCIUM CHLORIDEInactive
Quantity: 0.04 mg in 1 mL
Code: M4I0D6VV5M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
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