Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nalbuphine Hydrochloride
Product Details
NDC Product Code
0404-9917Application Number
ANDA070918Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSEffective Date
November 10, 2023NalbuphineActive
Code: ZU4275277RClass: ACTIBQuantity: 20 mg in 1 mL
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACTQuantity: 0.63 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACTQuantity: 1.8 mg in 1 mL
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACTQuantity: 0.47 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACTQuantity: 0.2 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT