NDC 0409-1467

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 ID0409-1467_703522d3-d2be-477d-98fc-c3ef719b1f10
NDC0409-1467
Product TypeHuman Prescription Drug
Proprietary NameNalbuphine Hydrochloride
Generic NameNalbuphine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2005-05-16
Marketing CategoryANDA / ANDA
Application NumberANDA070918
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 0409-1467-01

25 CARTON in 1 CASE (0409-1467-01) > 1 VIAL, MULTI-DOSE in 1 CARTON (0409-1467-61) > 10 mL in 1 VIAL, MULTI-DOSE
Marketing Start Date2005-05-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0409-1467-61 [00409146761]

Nalbuphine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA070918
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2020-02-24

NDC 0409-1467-01 [00409146701]

Nalbuphine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA070918
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-05-16

NDC 0409-1467-49 [00409146749]

Nalbuphine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA070918
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-09-06
Marketing End Date2015-07-27

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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