FDA.reportPublic FDA data

NDC 47781-408-11 - buprenorphine transdermal system

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
47781-408
Requested NDC
47781-408-11
Package NDCs from labels
47781-408-11, 47781-408-04
Manufacturer
Alvogen Inc.
Effective date
2025-09-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
buprenorphine transdermal system - Alvogen Inc.Alvogen Inc.2025-09-12HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
47781-408-042024-01-30C16284748780-11030e365-39fc-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for BUPRENORPHINE TRANSDERMAL SYSTEM. BUPRENORPHINE transdermal system, CIII Initial U.S. Approval: 1981

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47781-408-04buprenorphine transdermal system4 in 1 CARTONPATCH, EXTENDED RELEASE44
47781-408-11buprenorphine transdermal system168 h in 1 PATCHPATCH, EXTENDED RELEASE1684
47781-408-11buprenorphine transdermal system1 in 1 POUCHPATCH, EXTENDED RELEASE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47781-408BUPRENORPHINE TRANSDERMAL SYSTEM (BUPRENORPHINE) PATCH, EXTENDED RELEASE [ALVOGEN INC.]3Current NDC, Legacy NDC, 3 package rows20240316_315284b8-32ab-d34a-ea02-f501c6131bcc.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-408-04EA - Each47781-408ce995259-0e24-4a57-91b9-9bc7344cce2712022-11-07

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUBLOCADEBUPRENORPHINEIndivior Inc.6189fb21-9432-45f8-8481-0bfaf3ccde952026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 40D3SCR4GZ
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEBryant Ranch Prepack2063d5bf-b3bc-4e73-9046-7e994446ab502026-06-18Warnings, Adverse reactionsExact identifier
unii: 40D3SCR4GZ
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEBryant Ranch Prepackfc2755a5-3292-4b49-872d-e22c386a4e442026-06-11Warnings, Adverse reactionsExact identifier
unii: 40D3SCR4GZ
BuprenorphineBUPRENORPHINERhodes Pharmaceuticals LLC2738feae-316e-426f-971c-5f142ac01b602026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 904870
rxcui: 1432969
rxcui: 904880
rxcui: 904876
unii: 40D3SCR4GZ
BuprenorphineBUPRENORPHINETeva Pharmaceuticals USA, Inc.36995ce3-b515-447b-baa9-aa14f84060d82026-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 904870
rxcui: 1432969
rxcui: 904880
rxcui: 904876
unii: 40D3SCR4GZ
ButransBUPRENORPHINEKnoa Pharma LLC794aa355-66de-41b8-aedf-f2c40f6bc6642026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 904870
rxcui: 1432969
rxcui: 904880
rxcui: 904876
unii: 40D3SCR4GZ
BuprenorphineBUPRENORPHINEINGENUS PHARMACEUTICALS, LLC186e3be6-8bc0-4bb9-96f5-429d53632f452026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 904870
rxcui: 1432969
rxcui: 904880
rxcui: 904876
unii: 40D3SCR4GZ
BuprenorphineBUPRENORPHINEAveva Drug Delivery Systems Inc.1aae9b13-7431-42ef-8558-14a2325820e62026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 904870
rxcui: 1432969
rxcui: 904880
rxcui: 904876
unii: 40D3SCR4GZ
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONELannett Company, Inc.14eaa94a-cc8a-4e1e-8cfb-5c976c96c6062026-01-28Warnings, Adverse reactionsExact identifier
unii: 40D3SCR4GZ
BuprenorphineBUPRENORPHINEAmneal Pharmaceuticals NY LLCc7d079fb-507f-436f-b794-2171b7d970672026-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 904870
rxcui: 1432969
rxcui: 904880
rxcui: 904876
unii: 40D3SCR4GZ
BRIXADIBUPRENORPHINEBraeburn Inc.5d8a8fd0-8619-422a-a664-d1d2e8970f482025-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 40D3SCR4GZ
buprenorphine transdermal systemBUPRENORPHINEAlvogen Inc.315284b8-32ab-d34a-ea02-f501c6131bcc2025-09-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207490
ndc (package): 47781-408-11
ndc (package): 47781-407-04
ndc (package): 47781-419-11
ndc (package): 47781-419-04
ndc (package): 47781-408-04
ndc (package): 47781-406-04
ndc (package): 47781-406-11
ndc (package): 47781-407-11
ndc (product): 47781-406
ndc (product): 47781-408
ndc (product): 47781-407
ndc (product): 47781-419
ndc11 (package): 47781040811
rxcui: 904870
rxcui: 1432969
rxcui: 904880
rxcui: 904876
spl id: 7f83c8aa-7590-e2fe-4998-55323eadd112
spl set id: 315284b8-32ab-d34a-ea02-f501c6131bcc
unii: 40D3SCR4GZ

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.