NDC 0409-1465

Nalbuphine Hydrochloride

Nalbuphine Hydrochloride

Nalbuphine Hydrochloride is a Intramuscular; Intravenous; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Hospira, Inc.. The primary component is Nalbuphine Hydrochloride.

Product ID0409-1465_703522d3-d2be-477d-98fc-c3ef719b1f10
NDC0409-1465
Product TypeHuman Prescription Drug
Proprietary NameNalbuphine Hydrochloride
Generic NameNalbuphine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2004-12-31
Marketing CategoryANDA / ANDA
Application NumberANDA070916
Labeler NameHospira, Inc.
Substance NameNALBUPHINE HYDROCHLORIDE
Active Ingredient Strength20 mg/mL
Pharm ClassesCompetitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0409-1465-01

10 AMPULE in 1 TRAY (0409-1465-01) > 1 mL in 1 AMPULE (0409-1465-71)
Marketing Start Date2004-12-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0409-1465-01 [00409146501]

Nalbuphine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA070916
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2004-12-31

NDC 0409-1465-71 [00409146571]

Nalbuphine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA070916
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2020-02-24

NDC 0409-1465-49 [00409146549]

Nalbuphine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA070916
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2008-06-27
Marketing End Date2015-07-27

NDC 0409-1465-61 [00409146561]

Nalbuphine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA070916
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-09-06
Marketing End Date2013-10-23

Drug Details

Active Ingredients

IngredientStrength
NALBUPHINE HYDROCHLORIDE20 mg/mL

OpenFDA Data

SPL SET ID:6025e8d4-5083-4c3a-58a0-050e7b0b6150
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 904440
  • 904415
  • 1866543
  • 1866551

    • Pharmacological Class

    • Competitive Opioid Antagonists [MoA]
    • Opioid Agonist/Antagonist [EPC]
    • Partial Opioid Agonists [MoA]

    NDC Crossover Matching brand name "Nalbuphine Hydrochloride" or generic name "Nalbuphine Hydrochloride"

    NDCBrand NameGeneric Name
    0404-9917Nalbuphine Hydrochloridenalbuphine hydrochloride
    0404-9918Nalbuphine HydrochlorideNalbuphine Hydrochloride
    0404-9919Nalbuphine Hydrochloridenalbuphine hydrochloride
    0409-1463Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDE
    0409-1464Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDE
    0409-1465Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDE
    0409-1467Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDE
    52584-083Nalbuphine Hydrochloridenalbuphine hydrochloride
    52584-463Nalbuphine HydrochlorideNalbuphine Hydrochloride
    52584-464Nalbuphine Hydrochloridenalbuphine hydrochloride
    63739-466Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDE
    71872-7114Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDE
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