NDC 47781-355

Buprenorphine and Naloxone Sublingual Film

Buprenorphine And Naloxone

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

Product ID47781-355_1f9ca9d3-0382-549d-eac4-b45c4b4d81ad
NDC47781-355
Product TypeHuman Prescription Drug
Proprietary NameBuprenorphine and Naloxone Sublingual Film
Generic NameBuprenorphine And Naloxone
Dosage FormFilm
Route of AdministrationBUCCAL; SUBLINGUAL
Marketing Start Date2019-02-11
Marketing CategoryANDA / ANDA
Application NumberANDA205954
Labeler NameAlvogen Inc.
Substance NameBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
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 FlagN
Listing Certified Through2020-12-31

Packaging

NDC 47781-355-03

30 POUCH in 1 CARTON (47781-355-03) > 1 FILM in 1 POUCH (47781-355-11)
Marketing Start Date2019-02-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 47781-355-11 [47781035511]

Buprenorphine and Naloxone Sublingual Film FILM
Marketing CategoryANDA
Application NumberANDA205954
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-02-11

NDC 47781-355-03 [47781035503]

Buprenorphine and Naloxone Sublingual Film FILM
Marketing CategoryANDA
Application NumberANDA205954
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-02-11

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE2 mg/1

OpenFDA Data

SPL SET ID:4210afeb-474c-d842-d68e-af7e0021851a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1010600
  • 1307061
  • 1010604
  • 1307056
    • UPC Code
  • 0347781356118
  • 0347781357115
  • 0347781355111
  • 0347781358112

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Buprenorphine and Naloxone Sublingual Film" or generic name "Buprenorphine And Naloxone"

    NDCBrand NameGeneric Name
    47781-357Buprenorphine and Naloxone Sublingual FilmBuprenorphine and Naloxone Sublingual Film
    47781-355Buprenorphine and Naloxone Sublingual FilmBuprenorphine and Naloxone Sublingual Film
    47781-358Buprenorphine and Naloxone Sublingual FilmBuprenorphine and Naloxone Sublingual Film
    47781-356Buprenorphine and Naloxone Sublingual FilmBuprenorphine and Naloxone Sublingual Film
    52427-692Buprenorphine and Naloxone Sublingual FilmBuprenorphine and Naloxone Sublingual Film
    52427-694Buprenorphine and Naloxone Sublingual FilmBuprenorphine and Naloxone Sublingual Film
    52427-698Buprenorphine and Naloxone Sublingual FilmBuprenorphine and Naloxone Sublingual Film
    52427-712Buprenorphine and Naloxone Sublingual FilmBuprenorphine and Naloxone Sublingual Film
    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
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