NDC 59385-012

BUNAVAIL

Buprenorphine And Naloxone

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

Product ID59385-012_85676dad-14ee-42a3-aa71-9a80344c1197
NDC59385-012
Product TypeHuman Prescription Drug
Proprietary NameBUNAVAIL
Generic NameBuprenorphine And Naloxone
Dosage FormFilm
Route of AdministrationBUCCAL
Marketing Start Date2014-09-30
Marketing CategoryNDA / NDA
Application NumberNDA205637
Labeler NameBioDelivery Sciences International, Inc.
Substance NameBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
Active Ingredient Strength2 mg/1; mg/1
Pharm ClassesOpioid Antagonist [EPC],Opioid Antagonists [MoA],Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 59385-012-30

30 POUCH in 1 BOX (59385-012-30) > 1 FILM in 1 POUCH (59385-012-01)
Marketing Start Date2014-09-30
Marketing End Date2021-02-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59385-012-01 [59385001201]

BUNAVAIL FILM
Marketing CategoryNDA
Application NumberNDA205637
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-09-30

NDC 59385-012-30 [59385001230]

BUNAVAIL FILM
Marketing CategoryNDA
Application NumberNDA205637
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-09-30

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE2.1 mg/1

OpenFDA Data

SPL SET ID:12b963dd-f189-11e3-ac10-0800200c9a66
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1542390
  • 1544856
  • 1542396
  • 1544854
  • 1544853
  • 1544851

    • Pharmacological Class

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

    Medicade Reported Pricing

    59385001230 BUNAVAIL 2.1-0.3 MG FILM

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "BUNAVAIL" or generic name "Buprenorphine And Naloxone"

    NDCBrand NameGeneric Name
    59385-012BUNAVAILBUNAVAIL
    59385-014BUNAVAILBUNAVAIL
    59385-016BUNAVAILBUNAVAIL
    0228-3154Buprenorphine and NaloxoneBuprenorphine and Naloxone
    0228-3155Buprenorphine and NaloxoneBuprenorphine and Naloxone
    0378-8765Buprenorphine and NaloxoneBuprenorphine and Naloxone
    0378-8766Buprenorphine and NaloxoneBuprenorphine and Naloxone
    0378-8767Buprenorphine and Naloxonebuprenorphine and naloxone
    0378-8768Buprenorphine and Naloxonebuprenorphine and naloxone
    0406-1923Buprenorphine HCl and Naloxone HClBuprenorphine and Naloxone
    0406-1924Buprenorphine HCl and Naloxone HClBuprenorphine and Naloxone
    42291-174Buprenorphine HCl and Naloxone HClBuprenorphine and Naloxone

    Trademark Results [BUNAVAIL]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    BUNAVAIL
    BUNAVAIL
    85851211 4629312 Live/Registered
    BioDelivery Sciences International, Inc.
    2013-02-15
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