Nalbuphine hydrochloride
Nalbuphine Hydrochloride InjectionRx Only
Approved
Approval ID
a3221c05-5822-4ab8-b589-0e3939b91a68
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 26, 2025
Manufacturers
FDA
Somerset Therapeutics, LLC
DUNS: 079947873
Products 2
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 Code70069-671
Application NumberANDA216050
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nalbuphine hydrochloride
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Effective DateMarch 26, 2025
FDA Product Classification
INGREDIENTS (6)
NALBUPHINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: ZU4275277R
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Nalbuphine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70069-672
Application NumberANDA216050
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nalbuphine hydrochloride
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Effective DateMarch 26, 2025
FDA Product Classification
INGREDIENTS (5)
NALBUPHINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: ZU4275277R
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT