NDC 0054-0189

buprenorphine hydrochloride and naloxone hydrochloride dihydrate

Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate

buprenorphine hydrochloride and naloxone hydrochloride dihydrate is a Sublingual Tablet in the Human Prescription Drug category. It is labeled and distributed by Hikma Pharmaceuticals Usa Inc.. The primary component is Buprenorphine Hydrochloride; Naloxone Hydrochloride Dihydrate.

Product ID0054-0189_019288c8-bfb7-41d6-ad88-e608b8174bdf
NDC0054-0189
Product TypeHuman Prescription Drug
Proprietary Namebuprenorphine hydrochloride and naloxone hydrochloride dihydrate
Generic NameBuprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate
Dosage FormTablet
Route of AdministrationSUBLINGUAL
Marketing Start Date2014-06-27
Marketing CategoryANDA / ANDA
Application NumberANDA203326
Labeler NameHikma Pharmaceuticals USA Inc.
Substance NameBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
Active Ingredient Strength8 mg/1; mg/1
Pharm ClassesOpioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0054-0189-13

30 TABLET in 1 BOTTLE (0054-0189-13)
Marketing Start Date2014-06-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0054-0189-13 [00054018913]

buprenorphine hydrochloride and naloxone hydrochloride dihydrate TABLET
Marketing CategoryANDA
Application NumberANDA203326
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-06-27

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE8 mg/1

OpenFDA Data

SPL SET ID:713db2c6-0544-4633-b874-cfbeaf93db89
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351267
  • 351266
  • Pharmacological Class

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

    NDC Crossover Matching brand name "buprenorphine hydrochloride and naloxone hydrochloride dihydrate" or generic name "Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate"

    NDCBrand NameGeneric Name
    0054-0188buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrate
    0054-0189buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrate
    0406-8005Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBuprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate
    0406-8020Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBuprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate
    0904-7009buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrate
    0904-7010buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrate
    16729-549BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATEBUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE
    16729-550BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATEBUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE
    71335-1653buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrate
    71335-1725Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBuprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate
    71335-1720buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrate

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