NDC 70518-0711

Buprenorphine

Buprenorphine

Buprenorphine is a Sublingual Tablet in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Buprenorphine Hydrochloride.

Product ID70518-0711_6817aa07-f158-0dae-e053-2991aa0a3871
NDC70518-0711
Product TypeHuman Prescription Drug
Proprietary NameBuprenorphine
Generic NameBuprenorphine
Dosage FormTablet
Route of AdministrationSUBLINGUAL
Marketing Start Date2017-08-24
Marketing CategoryANDA / ANDA
Application NumberANDA201760
Labeler NameREMEDYREPACK INC.
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 70518-0711-1

100 TABLET in 1 BOTTLE, PLASTIC (70518-0711-1)
Marketing Start Date2017-08-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0711-1 [70518071101]

Buprenorphine TABLET
Marketing CategoryANDA
Application NumberANDA201760
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-11-10

NDC 70518-0711-2 [70518071102]

Buprenorphine TABLET
Marketing CategoryANDA
Application NumberANDA201760
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-11

NDC 70518-0711-0 [70518071100]

Buprenorphine TABLET
Marketing CategoryANDA
Application NumberANDA201760
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-24

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE2 mg/1

OpenFDA Data

SPL SET ID:fa2f8cfe-532d-4306-b35c-726044ad6299
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351264

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0093-3239BuprenorphineBuprenorphine
    0093-3600BuprenorphineBuprenorphine
    0093-3601BuprenorphineBuprenorphine
    0093-3602BuprenorphineBuprenorphine
    0093-3603BuprenorphineBuprenorphine
    0093-3656BuprenorphineBuprenorphine
    0093-3657BuprenorphineBuprenorphine
    0093-3658BuprenorphineBuprenorphine
    0093-3659BuprenorphineBuprenorphine
    0228-3153BuprenorphineBuprenorphine
    0228-3156BuprenorphineBuprenorphine
    70518-0711BuprenorphineBuprenorphine
    70518-1557BuprenorphineBuprenorphine
    70518-1625BuprenorphineBuprenorphine
    71335-0353BuprenorphineBuprenorphine
    71335-0950BUPRENORPHINEBUPRENORPHINE
    42858-586BuprenorphineBuprenorphine
    42858-750BuprenorphineBuprenorphine
    42858-502BUPRENORPHINEBUPRENORPHINE
    42858-501BUPRENORPHINEBUPRENORPHINE
    42858-353BuprenorphineBuprenorphine
    42858-839BuprenorphineBuprenorphine
    42858-493BuprenorphineBuprenorphine
    50090-2924BuprenorphineBuprenorphine
    55700-579BuprenorphineBuprenorphine
    55700-568BuprenorphineBuprenorphine
    58118-3156BuprenorphineBuprenorphine
    62756-459BuprenorphineBuprenorphine
    62756-460BuprenorphineBuprenorphine
    67046-994BuprenorphineBuprenorphine
    67046-995BuprenorphineBuprenorphine
    71335-1154BUPRENORPHINEBUPRENORPHINE
    70518-2218BUPRENORPHINEBUPRENORPHINE
    70518-2217BUPRENORPHINEBUPRENORPHINE
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