NDC 0054-0177

Buprenorphine HCl

Buprenorphine Hcl

Buprenorphine HCl 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.

Product ID0054-0177_0580f4ec-746e-4839-9ee0-dd1b24e7ff99
NDC0054-0177
Product TypeHuman Prescription Drug
Proprietary NameBuprenorphine HCl
Generic NameBuprenorphine Hcl
Dosage FormTablet
Route of AdministrationSUBLINGUAL
Marketing Start Date2009-10-08
Marketing CategoryANDA / ANDA
Application NumberANDA078633
Labeler NameHikma Pharmaceuticals USA Inc.
Substance NameBUPRENORPHINE HYDROCHLORIDE
Active Ingredient Strength8 mg/1
Pharm ClassesPartial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0054-0177-13

30 TABLET in 1 BOTTLE (0054-0177-13)
Marketing Start Date2009-10-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0054-0177-13 [00054017713]

Buprenorphine HCl TABLET
Marketing CategoryANDA
Application NumberANDA078633
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-10-08

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE8 mg/1

OpenFDA Data

SPL SET ID:1bf8b35a-b769-465c-a2f8-099868dfcd2f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351265
  • 351264
    • UPC Code
  • 0300540177133

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Buprenorphine HCl" or generic name "Buprenorphine Hcl"

    NDCBrand NameGeneric Name
    0054-0176Buprenorphine HClBuprenorphine HCl
    0054-0177Buprenorphine HClBuprenorphine HCl
    0904-7154Buprenorphine HClBuprenorphine HCl
    0904-7155Buprenorphine HClBuprenorphine HCl
    55700-302Buprenorphine HClBuprenorphine HCl
    55700-303Buprenorphine HClBuprenorphine HCl
    58118-0176Buprenorphine HClBuprenorphine HCl
    58118-0177Buprenorphine HClBuprenorphine HCl
    67046-998Buprenorphine HClBuprenorphine HCl
    67046-999Buprenorphine HClBuprenorphine HCl
    70518-2014Buprenorphine HClBuprenorphine HCl
    70518-2226Buprenorphine HClBuprenorphine HCl
    71335-1163Buprenorphine HClBuprenorphine HCl
    76519-1170BUPRENORPHINE HCLBUPRENORPHINE HCL
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