NDC 52427-712

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 Almatica Pharma Inc.. The primary component is Buprenorphine Hydrochloride; Naloxone Hydrochloride Dihydrate.

Product ID52427-712_38c4d210-ed50-b924-94da-7067eda6fa9f
NDC52427-712
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 NameAlmatica Pharma Inc.
Substance NameBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
Active Ingredient Strength12 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 52427-712-03

30 POUCH in 1 CARTON (52427-712-03) > 1 FILM in 1 POUCH (52427-712-11)
Marketing Start Date2019-02-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52427-712-11 [52427071211]

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

NDC 52427-712-03 [52427071203]

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 HYDROCHLORIDE12 mg/1

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.