NDC 76519-1170

BUPRENORPHINE HCL SL

Buprenorphine Hcl

BUPRENORPHINE HCL SL is a Sublingual Tablet in the Human Prescription Drug category. It is labeled and distributed by H.j. Harkins Company, Inc.. The primary component is Buprenorphine Hydrochloride.

Product ID76519-1170_77d3c308-58b9-2ab0-e053-2991aa0a4918
NDC76519-1170
Product TypeHuman Prescription Drug
Proprietary NameBUPRENORPHINE HCL SL
Generic NameBuprenorphine Hcl
Dosage FormTablet
Route of AdministrationSUBLINGUAL
Marketing Start Date2018-03-16
Marketing CategoryANDA / ANDA
Application NumberANDA078633
Labeler NameH.J. Harkins Company, 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 Through2019-12-31

Packaging

NDC 76519-1170-0

14 TABLET in 1 BOTTLE (76519-1170-0)
Marketing Start Date2018-03-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76519-1170-4 [76519117004]

BUPRENORPHINE HCL SL TABLET
Marketing CategoryANDA
Application NumberANDA078633
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-16
Inactivation Date2020-01-31

NDC 76519-1170-5 [76519117005]

BUPRENORPHINE HCL SL TABLET
Marketing CategoryANDA
Application NumberANDA078633
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-16
Inactivation Date2020-01-31

NDC 76519-1170-2 [76519117002]

BUPRENORPHINE HCL SL TABLET
Marketing CategoryANDA
Application NumberANDA078633
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-16
Inactivation Date2020-01-31

NDC 76519-1170-3 [76519117003]

BUPRENORPHINE HCL SL TABLET
Marketing CategoryANDA
Application NumberANDA078633
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-16
Inactivation Date2020-01-31

NDC 76519-1170-1 [76519117001]

BUPRENORPHINE HCL SL TABLET
Marketing CategoryANDA
Application NumberANDA078633
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-16
Inactivation Date2020-01-31

NDC 76519-1170-0 [76519117000]

BUPRENORPHINE HCL SL TABLET
Marketing CategoryANDA
Application NumberANDA078633
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-16
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE8 mg/1

OpenFDA Data

SPL SET ID:77d3c308-58b8-2ab0-e053-2991aa0a4918
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351265

    • Pharmacological Class

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

    NDC Crossover Matching brand name "BUPRENORPHINE HCL SL" 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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