Nalbuphine Hydrochloride

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

Medical Purchasing Solutions, LLC

DUNS Number

601458529

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

71872-7114

Application Number

ANDA070915

Marketing Category

ANDA (C73584)

Route of Administration

INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

Effective Date

May 23, 2023

Ingredients

TRISODIUM CITRATE DIHYDRATEInactive

Code: B22547B95KClass: IACTQuantity: 0.47 mg in 1 mL

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACTQuantity: 0.63 mg in 1 mL

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

METHYLPARABENInactive

Code: A2I8C7HI9TClass: IACTQuantity: 1.8 mg in 1 mL

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

PROPYLPARABENInactive

Code: Z8IX2SC1OHClass: IACTQuantity: 0.2 mg in 1 mL

Code: ZU4275277RClass: ACTIBQuantity: 10 mg in 1 mL

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT