NDC 58118-0176

Buprenorphine HCl

Buprenorphine Hcl

Buprenorphine HCl is a Sublingual Tablet in the Human Prescription Drug category. It is labeled and distributed by Clinical Solutions Wholesale, Llc. The primary component is Buprenorphine Hydrochloride.

Product ID58118-0176_784a8631-5dbf-4332-e053-2991aa0a0ed4
NDC58118-0176
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 NameClinical Solutions Wholesale, LLC
Substance NameBUPRENORPHINE HYDROCHLORIDE
Active Ingredient Strength2 mg/1
Pharm ClassesPartial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 58118-0176-8

30 TABLET in 1 BLISTER PACK (58118-0176-8)
Marketing Start Date2018-10-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58118-0176-8 [58118017608]

Buprenorphine HCl TABLET
Marketing CategoryANDA
Application NumberANDA078633
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-15

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE2 mg/1

OpenFDA Data

SPL SET ID:3a7418a2-bd6e-4082-b0fe-a5498e7b944a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351265
  • 351264

    • 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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