NDC 52584-463

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 General Injectables & Vaccines, Inc. The primary component is Nalbuphine Hydrochloride.

Product ID52584-463_06f64d94-78a5-49eb-b2d8-564a75dccc6a
NDC52584-463
Product TypeHuman Prescription Drug
Proprietary NameNalbuphine Hydrochloride
Generic NameNalbuphine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2010-03-01
Marketing CategoryANDA / ANDA
Application NumberANDA070914
Labeler NameGeneral Injectables & Vaccines, 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 52584-463-01

1 AMPULE in 1 BAG (52584-463-01) > 1 mL in 1 AMPULE
Marketing Start Date2010-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52584-463-01 [52584046301]

Nalbuphine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA070914
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-03-01

Drug Details

Active Ingredients

IngredientStrength
NALBUPHINE HYDROCHLORIDE10 mg/mL

OpenFDA Data

SPL SET ID:08290748-39dc-4f89-b582-b7eb8b482a2e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1866543
  • Pharmacological Class

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