"58064-408-04" National Drug Code (NDC)

Buprenorphine Transdermal System 4 POUCH in 1 CARTON (58064-408-04) / 1 PATCH in 1 POUCH (58064-408-11) / 168 h in 1 PATCH
(LTS Therapy Systems, LLC)

NDC Code58064-408-04
Package Description4 POUCH in 1 CARTON (58064-408-04) / 1 PATCH in 1 POUCH (58064-408-11) / 168 h in 1 PATCH
Product NDC58064-408
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameBuprenorphine Transdermal System
Non-Proprietary NameBuprenorphine
Dosage FormPATCH, EXTENDED RELEASE
UsageTRANSDERMAL
Start Marketing Date20220517
Marketing Category NameANDA
Application NumberANDA207490
ManufacturerLTS Therapy Systems, LLC
Substance NameBUPRENORPHINE
Strength20
Strength Unitug/h
Pharmacy ClassesPartial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
DEA ScheduleCIII

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