NDC 47781-419

buprenorphine transdermal system

Buprenorphine

buprenorphine transdermal system is a Transdermal Patch, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Alvogen Inc.. The primary component is Buprenorphine.

Product ID47781-419_d6f7d51f-5b73-5235-efc8-3e388d02b5d9
NDC47781-419
Product TypeHuman Prescription Drug
Proprietary Namebuprenorphine transdermal system
Generic NameBuprenorphine
Dosage FormPatch, Extended Release
Route of AdministrationTRANSDERMAL
Marketing Start Date2022-05-17
Marketing CategoryANDA /
Application NumberANDA207490
Labeler NameAlvogen Inc.
Substance NameBUPRENORPHINE
Active Ingredient Strength15 ug/h
Pharm ClassesPartial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 47781-419-04

4 POUCH in 1 CARTON (47781-419-04) > 1 PATCH in 1 POUCH (47781-419-11) > 168 h in 1 PATCH
Marketing Start Date2022-08-29
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "buprenorphine transdermal system" or generic name "Buprenorphine"

NDCBrand NameGeneric Name
0093-3239BuprenorphineBuprenorphine
0093-3600BuprenorphineBuprenorphine
0093-3601BuprenorphineBuprenorphine
0093-3602BuprenorphineBuprenorphine
0093-3603BuprenorphineBuprenorphine
0093-3656BuprenorphineBuprenorphine
0093-3657BuprenorphineBuprenorphine
0093-3658BuprenorphineBuprenorphine
0093-3659BuprenorphineBuprenorphine
0228-3153BuprenorphineBuprenorphine
0228-3156BuprenorphineBuprenorphine

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