Promethazine hydrochloride
Promethazine Hydrochloride Injection
Approved
Approval ID
01da3604-e28b-404e-8d14-ab3b9f8d03e3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 10, 2009
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-4021
Application NumberANDA040737
Product Classification
M
Marketing Category
C73584
G
Generic Name
Promethazine hydrochloride
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateAugust 9, 2010
FDA Product Classification
INGREDIENTS (8)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM METABISULFITEInactive
Quantity: 0.25 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 0.1 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
PROMETHAZINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 mL
Code: R61ZEH7I1I
Classification: ACTIB
PHENOLInactive
Quantity: 5 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
CALCIUM CHLORIDEInactive
Quantity: 0.04 mg in 1 mL
Code: M4I0D6VV5M
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
Promethazine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-2088
Application NumberANDA040737
Product Classification
M
Marketing Category
C73584
G
Generic Name
Promethazine hydrochloride
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateAugust 9, 2010
FDA Product Classification
INGREDIENTS (8)
PROMETHAZINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 mL
Code: R61ZEH7I1I
Classification: ACTIB
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
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 0.1 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT