NDC 0781-7238

BUPRENORPHINE AND NALOXONE

Buprenorphine Hydrochloride, Naloxone Hydrochloride

BUPRENORPHINE AND NALOXONE 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 ID0781-7238_05b87520-257c-47bb-8a4a-4aa08a175135
NDC0781-7238
Product TypeHuman Prescription Drug
Proprietary NameBUPRENORPHINE AND NALOXONE
Generic NameBuprenorphine Hydrochloride, Naloxone Hydrochloride
Dosage FormFilm, Soluble
Route of AdministrationBUCCAL; SUBLINGUAL
Marketing Start Date2019-02-19
Marketing End Date2021-04-30
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA022410
Labeler NameIndivior Inc.
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

Packaging

NDC 0781-7238-64

30 POUCH in 1 CARTON (0781-7238-64) > 1 FILM, SOLUBLE in 1 POUCH (0781-7238-06)
Marketing Start Date2019-02-19
Marketing End Date2021-04-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-7238-06 [00781723806]

BUPRENORPHINE AND NALOXONE FILM, SOLUBLE
Marketing CategoryNDA authorized generic
Application NumberNDA022410
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-02-19
Marketing End Date2021-04-30

NDC 0781-7238-64 [00781723864]

BUPRENORPHINE AND NALOXONE FILM, SOLUBLE
Marketing CategoryNDA authorized generic
Application NumberNDA022410
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-02-19
Marketing End Date2021-04-30

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE8 mg/1

OpenFDA Data

SPL SET ID:16695a4c-9e32-4a4d-8aa9-e10fd2412a46
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1010600
  • 1307061
  • 1010604
  • 1307056
    • UPC Code
  • 0307817227645
  • 0307817249647
  • 0307817238641
  • 0307817216649

    • Pharmacological Class

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

    NDC Crossover Matching brand name "BUPRENORPHINE AND NALOXONE" or generic name "Buprenorphine Hydrochloride, Naloxone Hydrochloride"

    NDCBrand NameGeneric Name
    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
    0781-7216BUPRENORPHINE AND NALOXONEbuprenorphine hydrochloride, naloxone hydrochloride
    0781-7249BUPRENORPHINE AND NALOXONEBUPRENORPHINE AND NALOXONE
    0781-7227BUPRENORPHINE AND NALOXONEBUPRENORPHINE AND NALOXONE
    0781-7238BUPRENORPHINE AND NALOXONEBUPRENORPHINE AND NALOXONE
    43598-579Buprenorphine and NaloxoneBuprenorphine and Naloxone
    43598-580Buprenorphine and NaloxoneBuprenorphine and Naloxone
    43598-582Buprenorphine and NaloxoneBuprenorphine and Naloxone
    43598-581Buprenorphine and NaloxoneBuprenorphine and Naloxone
    50383-294Buprenorphine and NaloxoneBuprenorphine and Naloxone
    50383-287Buprenorphine and NaloxoneBuprenorphine and Naloxone
    53217-138Buprenorphine and NaloxoneBuprenorphine and Naloxone
    60429-587Buprenorphine and NaloxoneBuprenorphine and Naloxone
    60429-586Buprenorphine and NaloxoneBuprenorphine and Naloxone
    62175-452Buprenorphine and NaloxoneBuprenorphine and Naloxone
    62756-969Buprenorphine and NaloxoneBuprenorphine and Naloxone
    62175-458Buprenorphine and NaloxoneBuprenorphine and Naloxone
    62756-970Buprenorphine and NaloxoneBuprenorphine and Naloxone
    63629-7270Buprenorphine and NaloxoneBuprenorphine and Naloxone
    70518-2327Buprenorphine and NaloxoneBuprenorphine and Naloxone
    70518-2311Buprenorphine and NaloxoneBuprenorphine and Naloxone
    0406-1923Buprenorphine HCl and Naloxone HClBuprenorphine and Naloxone
    0406-1924Buprenorphine HCl and Naloxone HClBuprenorphine and Naloxone
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