NALBUPHINE HCI
NALBUPHINE HCI INJECTION 20mg/mL 10mL VIAL
Approved
Approval ID
96128b54-24d6-88a3-e053-2a95a90a1c9c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 22, 2020
Manufacturers
FDA
HF Acquisition Co LLC, DBA HealthFirst
DUNS: 045657305
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
NALBUPHINE HCI
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51662-1418
Application NumberANDA070918
Product Classification
M
Marketing Category
C73584
G
Generic Name
NALBUPHINE HCI
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Effective DateFebruary 22, 2020
FDA Product Classification
INGREDIENTS (9)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
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
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
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
TRISODIUM CITRATE DIHYDRATEInactive
Quantity: 0.47 mg in 1 mL
Code: B22547B95K
Classification: IACT