Nalbuphine Hydrochloride
Nalbuphine Hydrochloride
Approved
Approval ID
8f5a8af6-ffbd-42ba-9313-083db14966fe
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 10, 2023
Manufacturers
FDA
Henry Schein, Inc.
DUNS: 012430880
Products 1
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 Code0404-9919
Application NumberANDA070915
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS
Effective DateNovember 10, 2023
Generic Namenalbuphine hydrochloride
INGREDIENTS (9)
NALBUPHINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: ZU4275277R
Classification: ACTIB
TRISODIUM CITRATE DIHYDRATEInactive
Quantity: 0.47 mg in 1 mL
Code: B22547B95K
Classification: IACT
METHYLPARABENInactive
Quantity: 1.8 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
PROPYLPARABENInactive
Quantity: 0.2 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Quantity: 0.63 mg in 1 mL
Code: XF417D3PSL
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT