NDC 52584-083

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 And Vaccines,inc.. The primary component is Nalbuphine Hydrochloride.

Product ID52584-083_0e1346b6-7c47-4957-b0be-849a84b18a89
NDC52584-083
Product TypeHuman Prescription Drug
Proprietary NameNalbuphine Hydrochloride
Generic NameNalbuphine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2021-04-19
Marketing CategoryANDA /
Application NumberANDA070918
Labeler NameGeneral Injectables and Vaccines,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 Through2022-12-31

Packaging

NDC 52584-083-61

1 VIAL, MULTI-DOSE in 1 BAG (52584-083-61) > 10 mL in 1 VIAL, MULTI-DOSE
Marketing Start Date2021-04-19
NDC Exclude FlagN
Sample Package?N

Drug Details

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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