Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Hikma Pharmaceuticals USA Inc.
001230762
Products2
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
0641-0956Application Number
ANDA083312Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAREffective Date
April 22, 2022PromethazineActive
Code: R61ZEH7I1IClass: ACTIBQuantity: 50 mg in 1 mL
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACTQuantity: 0.1 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACT
CALCIUM CHLORIDEInactive
Code: M4I0D6VV5MClass: IACTQuantity: 0.04 mg in 1 mL
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACTQuantity: 0.25 mg in 1 mL
PHENOLInactive
Code: 339NCG44TVClass: IACTQuantity: 5 mg in 1 mL
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACT
Promethazine Hydrochloride
Product Details
NDC Product Code
0641-0955Application Number
ANDA083312Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAR, INTRAVENOUSEffective Date
April 22, 2022SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACT
PromethazineActive
Code: R61ZEH7I1IClass: ACTIBQuantity: 25 mg in 1 mL
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACTQuantity: 0.1 mg in 1 mL
CALCIUM CHLORIDEInactive
Code: M4I0D6VV5MClass: IACTQuantity: 0.04 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACTQuantity: 0.25 mg in 1 mL
PHENOLInactive
Code: 339NCG44TVClass: IACTQuantity: 5 mg in 1 mL
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACT