NDC 59385-021

BELBUCA

Buprenorphine Hydrochloride

BELBUCA is a Buccal Film, Soluble in the Human Prescription Drug category. It is labeled and distributed by Biodelivery Sciences International Inc. The primary component is Buprenorphine Hydrochloride.

Product ID59385-021_107b0f99-9af8-4ddc-aea9-1d949f71cddd
NDC59385-021
Product TypeHuman Prescription Drug
Proprietary NameBELBUCA
Generic NameBuprenorphine Hydrochloride
Dosage FormFilm, Soluble
Route of AdministrationBUCCAL
Marketing Start Date2017-09-01
Marketing CategoryNDA / NDA
Application NumberNDA207932
Labeler NameBioDelivery Sciences International Inc
Substance NameBUPRENORPHINE HYDROCHLORIDE
Active Ingredient Strength75 ug/1
Pharm ClassesPartial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 59385-021-60

60 POUCH in 1 CARTON (59385-021-60) > 1 FILM, SOLUBLE in 1 POUCH (59385-021-01)
Marketing Start Date2017-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59385-021-01 [59385002101]

BELBUCA FILM, SOLUBLE
Marketing CategoryNDA
Application NumberNDA207932
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-09-01

NDC 59385-021-60 [59385002160]

BELBUCA FILM, SOLUBLE
Marketing CategoryNDA
Application NumberNDA207932
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-09-01

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE75 ug/1

OpenFDA Data

SPL SET ID:bc2b7a3d-72cf-497c-95b0-ba2b71f63c64
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1716090
  • 1716079
  • 1716086
  • 1716069
  • 1716057
  • 1716081
  • 1716083
  • 1716075
  • 1716063
  • 1716077
  • 1716071
  • 1716067
  • 1716073
  • 1716065

    • Pharmacological Class

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

    Medicade Reported Pricing

    59385002160 BELBUCA 75 MCG FILM

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    55700-867BELBUCAbuprenorphine hydrochloride
    59385-025BELBUCABELBUCA
    59385-021BELBUCABELBUCA
    59385-022BELBUCABELBUCA
    59385-023BELBUCABELBUCA
    59385-024BELBUCABELBUCA
    59385-026BELBUCABELBUCA
    59385-027BELBUCABELBUCA
    12496-0757Buprenexbuprenorphine hydrochloride
    50090-2924BuprenorphineBuprenorphine Hydrochloride
    0143-9246Buprenorphine HydrochlorideBuprenorphine Hydrochloride
    0409-2012Buprenorphine HydrochlorideBuprenorphine Hydrochloride
    0517-0725Buprenorphine HydrochlorideBuprenorphine Hydrochloride
    21695-515Buprenorphine HydrochlorideBuprenorphine Hydrochloride
    35356-556buprenorphine hydrochloridebuprenorphine hydrochloride
    42023-179Buprenorphine HydrochlorideBuprenorphine Hydrochloride
    50090-1571buprenorphine hydrochloridebuprenorphine hydrochloride
    50383-924buprenorphine hydrochloridebuprenorphine hydrochloride
    50383-930buprenorphine hydrochloridebuprenorphine hydrochloride
    53217-246buprenorphine hydrochloridebuprenorphine hydrochloride
    52440-100Probuphinebuprenorphine hydrochloride

    Trademark Results [BELBUCA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    BELBUCA
    BELBUCA
    86235385 4946787 Live/Registered
    BIODELIVERY SCIENCES INTERNATIONAL, INC.
    2014-03-28
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