NDC 47781-400

buprenorphine buccal film

Buprenorphine Buccal

buprenorphine buccal film is a Buccal Film in the Human Prescription Drug category. It is labeled and distributed by Alvogen, Inc.. The primary component is Buprenorphine Hydrochloride.

Product ID47781-400_62b1a9fe-2e29-1535-e7d6-327240efa309
NDC47781-400
Product TypeHuman Prescription Drug
Proprietary Namebuprenorphine buccal film
Generic NameBuprenorphine Buccal
Dosage FormFilm
Route of AdministrationBUCCAL
Marketing Start Date2021-08-04
Marketing CategoryANDA /
Application NumberANDA211594
Labeler NameAlvogen, Inc.
Substance NameBUPRENORPHINE HYDROCHLORIDE
Active Ingredient Strength300 ug/1
Pharm ClassesPartial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 47781-400-74

60 POUCH in 1 CARTON (47781-400-74) > 1 FILM in 1 POUCH (47781-400-11)
Marketing Start Date2021-08-04
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "buprenorphine buccal film" or generic name "Buprenorphine Buccal"

NDCBrand NameGeneric Name
47781-400buprenorphine buccal filmbuprenorphine buccal
47781-425buprenorphine buccal filmbuprenorphine buccal
47781-471buprenorphine buccal filmbuprenorphine buccal
47781-472buprenorphine buccal filmbuprenorphine buccal
47781-473buprenorphine buccal filmbuprenorphine buccal
47781-474buprenorphine buccal filmbuprenorphine buccal
47781-475buprenorphine buccal filmbuprenorphine buccal

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