Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PROMETHAZINE HYDROCHLORIDE
Product Details
NDC Product Code
39822-5550Application Number
ANDA040737Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAR, INTRAVENOUSEffective Date
January 9, 2024CALCIUM CHLORIDEInactive
Code: M4I0D6VV5MClass: IACTQuantity: 0.01 mg in 1 mL
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACTQuantity: 0.25 mg in 1 mL
EDETATE SODIUMInactive
Code: MP1J8420LUClass: IACTQuantity: 0.1 mg in 1 mL
PHENOLInactive
Code: 339NCG44TVClass: IACTQuantity: 5 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACT
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACT
PromethazineActive
Code: R61ZEH7I1IClass: ACTIBQuantity: 50 mg in 1 mL