NDC 63629-4028

Suboxone

Buprenorphine And Naloxone

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

Product ID63629-4028_897164c4-714d-4b8a-8b6a-9ffc7f3627a0
NDC63629-4028
Product TypeHuman Prescription Drug
Proprietary NameSuboxone
Generic NameBuprenorphine And Naloxone
Dosage FormFilm, Soluble
Route of AdministrationSUBLINGUAL
Marketing Start Date2010-09-13
Marketing CategoryNDA / NDA
Application NumberNDA022410
Labeler NameBryant Ranch Prepack
Substance NameBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Active Ingredient Strength2 mg/1; mg/1
Pharm ClassesPartial Opioid Agonists [MoA],Partial Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA]
DEA ScheduleCIII
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 63629-4028-1

10 FILM, SOLUBLE in 1 BOTTLE (63629-4028-1)
Marketing Start Date2010-09-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-4028-1 [63629402801]

Suboxone FILM, SOLUBLE
Marketing CategoryNDA
Application NumberNDA022410
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-09-13
Inactivation Date2019-11-27

NDC 63629-4028-2 [63629402802]

Suboxone FILM, SOLUBLE
Marketing CategoryNDA
Application NumberNDA022410
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-09-13
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE2 mg/1

OpenFDA Data

SPL SET ID:033f2324-09d4-ce5c-ff60-e3b03d0538c1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1010600
  • 1010603

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    12496-1202Suboxonebuprenorphine hydrochloride, naloxone hydrochloride
    12496-1212SuboxoneSuboxone
    12496-1204SuboxoneSuboxone
    12496-1208SuboxoneSuboxone
    53217-328SuboxoneSuboxone
    55700-147SuboxoneSuboxone
    63629-4028SuboxoneSuboxone
    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

    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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.