Nalbuphine Hydrochloride
NALBUPHINE HYDROCHLORIDE
Approved
Approval ID
6025e8d4-5083-4c3a-58a0-050e7b0b6150
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2024
Manufacturers
FDA
Hospira, Inc.
DUNS: 141588017
Products 4
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 Code0409-1464
Application NumberANDA070915
Product Classification
M
Marketing Category
C73584
G
Generic Name
NALBUPHINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Effective DateDecember 1, 2022
FDA Product Classification
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
ANHYDROUS CITRIC ACIDInactive
Quantity: 0.63 mg in 1 mL
Code: XF417D3PSL
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
METHYLPARABENInactive
Quantity: 1.8 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Quantity: 0.2 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
NALBUPHINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0409-1463
Application NumberANDA070914
Product Classification
M
Marketing Category
C73584
G
Generic Name
NALBUPHINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Effective DateDecember 1, 2022
FDA Product Classification
INGREDIENTS (7)
NALBUPHINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: ZU4275277R
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Quantity: 0.63 mg in 1 mL
Code: XF417D3PSL
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Quantity: 0.47 mg in 1 mL
Code: B22547B95K
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
NALBUPHINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0409-1465
Application NumberANDA070916
Product Classification
M
Marketing Category
C73584
G
Generic Name
NALBUPHINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Effective DateDecember 1, 2022
FDA Product Classification
INGREDIENTS (7)
TRISODIUM CITRATE DIHYDRATEInactive
Quantity: 0.47 mg in 1 mL
Code: B22547B95K
Classification: IACT
NALBUPHINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: ZU4275277R
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Quantity: 0.63 mg in 1 mL
Code: XF417D3PSL
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
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 Code0409-1467
Application NumberANDA070918
Product Classification
M
Marketing Category
C73584
G
Generic Name
NALBUPHINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Effective DateDecember 1, 2022
FDA Product Classification
INGREDIENTS (9)
NALBUPHINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: ZU4275277R
Classification: ACTIB
TRISODIUM CITRATE DIHYDRATEInactive
Quantity: 0.47 mg in 1 mL
Code: B22547B95K
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Quantity: 0.63 mg in 1 mL
Code: XF417D3PSL
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
PROPYLPARABENInactive
Quantity: 0.2 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
METHYLPARABENInactive
Quantity: 1.8 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT