NDC 12496-1208

Suboxone

Buprenorphine Hydrochloride, Naloxone Hydrochloride

Suboxone is a Buccal; Sublingual Film, Soluble in the Human Prescription Drug category. It is labeled and distributed by Indivior Inc.. The primary component is Buprenorphine Hydrochloride; Naloxone Hydrochloride.

Product ID12496-1208_1e2afa2f-2bc7-481c-a1f6-97632642199f
NDC12496-1208
Product TypeHuman Prescription Drug
Proprietary NameSuboxone
Generic NameBuprenorphine Hydrochloride, Naloxone Hydrochloride
Dosage FormFilm, Soluble
Route of AdministrationBUCCAL; SUBLINGUAL
Marketing Start Date2010-09-13
Marketing CategoryNDA / NDA
Application NumberNDA022410
Labeler NameIndivior Inc.
Substance NameBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Active Ingredient Strength8 mg/1; mg/1
Pharm ClassesOpioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 12496-1208-3

30 POUCH in 1 CARTON (12496-1208-3) > 1 FILM, SOLUBLE in 1 POUCH (12496-1208-1)
Marketing Start Date2010-09-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 12496-1208-1 [12496120801]

Suboxone FILM, SOLUBLE
Marketing CategoryNDA
Application NumberNDA022410
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-09-13

NDC 12496-1208-3 [12496120803]

Suboxone FILM, SOLUBLE
Marketing CategoryNDA
Application NumberNDA022410
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-09-13

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE8 mg/1

OpenFDA Data

SPL SET ID:8a5edcf9-828c-4f97-b671-268ab13a8ecd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1010600
  • 1010603
  • 1010604
  • 1010606
  • 1307058
  • 1307063
  • 1307061
  • 1307056
  • UPC Code
  • 0312496120835
  • 0312496120439
  • 0312496120231
  • 0312496121238
  • Pharmacological Class

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

    Medicade Reported Pricing

    12496120803 SUBOXONE 8 MG-2 MG SL FILM

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Suboxone" or generic name "Buprenorphine Hydrochloride, Naloxone Hydrochloride"

    NDCBrand NameGeneric Name
    12496-1202Suboxonebuprenorphine hydrochloride, naloxone hydrochloride
    12496-1204Suboxonebuprenorphine hydrochloride, naloxone hydrochloride
    12496-1212SuboxoneSuboxone
    12496-1208SuboxoneSuboxone
    53217-328SuboxoneSuboxone
    55700-147SuboxoneSuboxone
    63629-4028SuboxoneSuboxone
    0781-7216BUPRENORPHINE AND NALOXONEbuprenorphine hydrochloride, naloxone hydrochloride
    0781-7227BUPRENORPHINE AND NALOXONEbuprenorphine hydrochloride, naloxone hydrochloride
    0781-7238BUPRENORPHINE AND NALOXONEbuprenorphine hydrochloride, naloxone hydrochloride
    0781-7249BUPRENORPHINE AND NALOXONEbuprenorphine hydrochloride, naloxone hydrochloride

    Trademark Results [Suboxone]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SUBOXONE
    SUBOXONE
    78303449 2917297 Dead/Cancelled
    Reckitt Benckiser Healthcare (UK) Limited
    2003-09-22
    SUBOXONE
    SUBOXONE
    77727995 3917631 Live/Registered
    INDIVIOR UK LIMITED
    2009-05-04
    SUBOXONE
    SUBOXONE
    75226449 2169133 Live/Registered
    INDIVIOR UK LIMITED
    1997-01-16

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