Nalbuphine Hydrochloride
Nalbuphine Hydrochloride
Approved
Approval ID
80e454d8-06ac-454e-af1e-c01452b285e7
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0404-9917
Application NumberANDA070918
Product Classification
M
Marketing Category
C73584
G
Generic Name
nalbuphine hydrochloride
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Effective DateNovember 10, 2023
FDA Product Classification
INGREDIENTS (9)
NALBUPHINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: ZU4275277R
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Quantity: 0.63 mg in 1 mL
Code: XF417D3PSL
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
METHYLPARABENInactive
Quantity: 1.8 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Quantity: 0.47 mg in 1 mL
Code: B22547B95K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
PROPYLPARABENInactive
Quantity: 0.2 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT