NDC 70518-2218

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 ID70518-2218_8e3c4aa6-bad9-2485-e053-2995a90add40
NDC70518-2218
Product TypeHuman Prescription Drug
Proprietary NameBUPRENORPHINE
Generic NameBuprenorphine
Dosage FormTablet
Route of AdministrationSUBLINGUAL
Marketing Start Date2019-07-15
Marketing CategoryANDA / ANDA
Application NumberANDA207276
Labeler NameREMEDYREPACK 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 Through2020-12-31

Packaging

NDC 70518-2218-0

30 TABLET in 1 BLISTER PACK (70518-2218-0)
Marketing Start Date2019-07-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-2218-0 [70518221800]

BUPRENORPHINE TABLET
Marketing CategoryANDA
Application NumberANDA207276
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-15

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE8 mg/1

OpenFDA Data

SPL SET ID:5cbcde4b-24eb-4f8d-bee3-085da4b5e372
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351265
  • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.