NDC 0404-9918

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 Henry Schein, Inc.. The primary component is Nalbuphine Hydrochloride.

Product ID0404-9918_91e993b7-8701-4b9e-a0cb-c6f0918993be
NDC0404-9918
Product TypeHuman Prescription Drug
Proprietary NameNalbuphine Hydrochloride
Generic NameNalbuphine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2022-01-13
Marketing CategoryANDA /
Application NumberANDA070914
Labeler NameHenry Schein, 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 Through2023-12-31

Packaging

NDC 0404-9918-01

1 AMPULE in 1 BAG (0404-9918-01) > 1 mL in 1 AMPULE
Marketing Start Date2022-01-13
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.