NDC 53217-328

Suboxone

Buprenorphine Hydrochloride, Naloxone Hydrochloride

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

Product ID53217-328_4f1210ae-a8ec-4253-b825-35e66ac93a1c
NDC53217-328
Product TypeHuman Prescription Drug
Proprietary NameSuboxone
Generic NameBuprenorphine Hydrochloride, Naloxone Hydrochloride
Dosage FormFilm, Soluble
Route of AdministrationSUBLINGUAL
Marketing Start Date2010-09-13
Marketing CategoryNDA / NDA
Application NumberNDA022410
Labeler NameAidarex Pharmaceuticals LLC
Substance NameBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Active Ingredient Strength8 mg/1; mg/1
Pharm ClassesPartial Opioid Agonists [MoA],Partial Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53217-328-01

30 POUCH in 1 CARTON (53217-328-01) > 1 FILM, SOLUBLE in 1 POUCH
Marketing Start Date2010-09-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53217-328-01 [53217032801]

Suboxone FILM, SOLUBLE
Marketing CategoryNDA
Application NumberNDA022410
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-09-13
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE8 mg/1

OpenFDA Data

SPL SET ID:54c487ac-750b-462e-a4cb-dcab1dd43ba8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1010604
  • 1010606
  • 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 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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