NDC 60687-481

Buprenorphine

Buprenorphine

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

Product ID60687-481_9bb74582-2451-fe1d-e053-2995a90a9868
NDC60687-481
Product TypeHuman Prescription Drug
Proprietary NameBuprenorphine
Generic NameBuprenorphine
Dosage FormTablet
Route of AdministrationSUBLINGUAL
Marketing Start Date2020-02-01
Marketing CategoryANDA / ANDA
Application NumberANDA207276
Labeler NameAmerican Health Packaging
Substance NameBUPRENORPHINE HYDROCHLORIDE
Active Ingredient Strength2 mg/1
Pharm ClassesPartial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 60687-481-21

30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-481-21) > 1 TABLET in 1 BLISTER PACK (60687-481-11)
Marketing Start Date2020-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60687-481-21 [60687048121]

Buprenorphine TABLET
Marketing CategoryANDA
Application NumberANDA207276
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-02-01

NDC 60687-481-11 [60687048111]

Buprenorphine TABLET
Marketing CategoryANDA
Application NumberANDA207276
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-02-01

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE2 mg/1

OpenFDA Data

SPL SET ID:8d38f7aa-da0b-40ad-b0d1-4284c71042ed
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" 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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