NDC 0409-1463

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 ID0409-1463_099d9c45-f59e-4971-a6c5-e26407578927
NDC0409-1463
Product TypeHuman Prescription Drug
Proprietary NameNalbuphine Hydrochloride
Generic NameNalbuphine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2008-06-27
Marketing CategoryANDA / ANDA
Application NumberANDA070914
Labeler NameHospira, Inc.
Substance NameNALBUPHINE HYDROCHLORIDE
Active Ingredient Strength10 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 0409-1463-01

10 AMPULE in 1 TRAY (0409-1463-01) > 1 mL in 1 AMPULE (0409-1463-71)
Marketing Start Date2005-03-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0409-1463-61 [00409146361]

Nalbuphine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA070914
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-09-06
Marketing End Date2013-10-23

NDC 0409-1463-69 [00409146369]

Nalbuphine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA070914
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2020-02-05

NDC 0409-1463-01 [00409146301]

Nalbuphine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA070914
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-03-31

NDC 0409-1463-49 [00409146349]

Nalbuphine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA070914
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2008-06-27

NDC 0409-1463-71 [00409146371]

Nalbuphine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA070914
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2020-02-24

Drug Details

Active Ingredients

IngredientStrength
NALBUPHINE HYDROCHLORIDE10 mg/mL

OpenFDA Data

SPL SET ID:a99fe500-f52b-483c-807c-178f1a78a02b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1866543
  • 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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