NDC 60505-7076

Buprenorphene

Buprenorphene

Buprenorphene is a Transdermal Patch, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Apotex Corp.. The primary component is Buprenorphine.

Product ID60505-7076_47eb2ff6-1cee-2ea0-558c-99d51c900b13
NDC60505-7076
Product TypeHuman Prescription Drug
Proprietary NameBuprenorphene
Generic NameBuprenorphene
Dosage FormPatch, Extended Release
Route of AdministrationTRANSDERMAL
Marketing Start Date2021-09-29
Marketing CategoryANDA /
Application NumberANDA210272
Labeler NameApotex Corp.
Substance NameBUPRENORPHINE
Active Ingredient Strength8 mg/h
Pharm ClassesPartial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 60505-7076-5

4 POUCH in 1 CARTON (60505-7076-5) > 1 PATCH in 1 POUCH > 168 h in 1 PATCH
Marketing Start Date2021-09-29
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Buprenorphene" or generic name "Buprenorphene"

NDCBrand NameGeneric Name
60505-7075BuprenorpheneBuprenorphene
60505-7076BuprenorpheneBuprenorphene
60505-7077BuprenorpheneBuprenorphene
60505-7078BuprenorpheneBuprenorphene
60505-7079BuprenorpheneBuprenorphene

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