FDA.reportPublic FDA data

NDC 47781-357-11 - Buprenorphine and Naloxone Sublingual Film

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
47781-357
Requested NDC
47781-357-11
Package NDCs from labels
47781-357-11, 47781-357-03
Manufacturer
Redpharm Drug
Effective date
2026-08-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Buprenorphine and Naloxone Sublingual Film - Redpharm DrugRedpharm Drug2026-08-12HUMAN PRESCRIPTION DRUG LABEL
Buprenorphine and Naloxone Sublingual Film - Redpharm DrugRedpharm Drug2026-06-13HUMAN PRESCRIPTION DRUG LABEL
Buprenorphine and Naloxone Sublingual Film - Alvogen Inc.Alvogen Inc.2026-01-01HUMAN PRESCRIPTION DRUG LABEL
Buprenorphine and Naloxone Sublingual Film - Redpharm DrugRedpharm Drug2025-12-27HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
47781-357-032024-01-30C16284748780-11030e365-26aa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM. BUPRENORPHINE and NALOXONE sublingual film, for sublingual or buccal use, CIII. Initial U.S. Approval: 2002
47781-357-032024-01-30C16284748780-11030e365-26aa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM. BUPRENORPHINE and NALOXONE sublingual film, for sublingual or buccal use, CIII. Initial U.S. Approval: 2002
47781-357-032024-01-30C16284748780-11030e365-26aa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM. BUPRENORPHINE and NALOXONE sublingual film, for sublingual or buccal use, CIII Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47781-357-03Buprenorphine and Naloxone Sublingual Film30 in 1 CARTONFILM3019
47781-357-11Buprenorphine and Naloxone Sublingual Film1 in 1 POUCHFILM119

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47781-357BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM (BUPRENORPHINE AND NALOXONE ) FILM [ALVOGEN INC.]17Current NDC, Legacy NDC, 2 package rows20240215_4210afeb-474c-d842-d68e-af7e0021851a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-357-03EA - Each47781-3573c6b54ad-507e-4736-9bcb-b2e62c6cbc0712019-02-13
47781-357-11EA - Each47781-357400e75cb-aa2c-4a29-a011-be09c4c8828712019-10-07

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 29 of 287 · 5,723 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BUPRENORPHINEBUPRENORPHINEUnit Dose Solutions, Inc.5479b218-a388-2c3c-e063-6294a90a0e852026-06-17Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Smart Care Hand Sanitizer Holiday-Sugar CookieALCOHOLShenzhen Lantern Scicence Co.,Ltd.547e55a6-7d63-2344-e063-6294a90ab4c02026-06-17WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Holiday- GingerbreadALCOHOLShenzhen Lantern Scicence Co.,Ltd.547e76d4-e7ea-5cac-e063-6394a90a72942026-06-17WarningsExact identifier
unii: 3K9958V90M
Smart Care Holiday Hand Sanitizer-Sugar CookieALCOHOLShenzhen Lantern Scicence Co.,Ltd.547eaf43-ec33-b61a-e063-6294a90af6d92026-06-17WarningsExact identifier
unii: 3K9958V90M
Smart Care Holiday Hand Sanitizer-Candy CaneALCOHOLShenzhen Lantern Scicence Co.,Ltd.547ef4f4-6f0b-23ea-e063-6294a90a75332026-06-17WarningsExact identifier
unii: 3K9958V90M
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLP & L Development, LLCfcda76cb-63c4-4e81-9e0a-13be506a81502026-06-17WarningsExact identifier
unii: ND2M416302
BUPRENORPHINEBUPRENORPHINEBryant Ranch Prepack966adb01-71b4-4e0b-bbc6-b83da9987aa22026-06-16Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Novo WipeNOVO WIPESHENZHEN BENLIJU BIO-TECH CO.,LTD545c6386-139e-cb9b-e063-6394a90a04562026-06-16WarningsExact identifier
unii: 3K9958V90M
GlowBiotics Tinted Sunscreen SPF 30ZINC OXIDERum Brands, LLC544dba29-4785-4ab6-e063-6394a90a17b32026-06-16WarningsExact identifier
unii: 15FIX9V2JP
Societe Prime and DefendZINC OXIDE SUNSCREENSociete Clinical Skincare5439bd31-5ee1-9bca-e063-6394a90a748c2026-06-16WarningsExact identifier
unii: 15FIX9V2JP
Societe CoverShield Tinted SPFZINC OXIDESociete Clinical Skincare545efbc4-82d4-f126-e063-6294a90a97102026-06-16WarningsExact identifier
unii: 15FIX9V2JP
BuprenorphineBUPRENORPHINEMajor Pharmaceuticalsdba586f9-e3f2-4b9c-849b-907c81a5a0ef2026-06-16Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEBryant Ranch Prepackfe023dbf-e165-4b7f-a211-bd14696f1e2c2026-06-16Warnings, Adverse reactionsExact identifier
unii: 5Q187997EE
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEBryant Ranch Prepack4b1df792-f56c-4c0c-92b0-a887f42255672026-06-16Warnings, Adverse reactionsExact identifier
unii: 5Q187997EE
unii: 56W8MW3EN1
Shield by HEALTHY SKIN LAB MD SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEHEALTHY SKIN LAB LIMITED6838b754-9915-48ff-af35-5338dbd06ac42026-06-15WarningsExact identifier
unii: 15FIX9V2JP
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd.395aec48-198a-4aed-8e38-7accfb3232f92026-06-15Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
unii: B22547B95K
70%ISOPROPYL ALCOHOLMeijer, Inc.7b1f93ff-5eeb-4da1-8f02-7c47d713689a2026-06-15Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLMeijer, Inc.531cea18-9609-4d78-876d-3ba5d2d1e16f2026-06-15Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLMeijer, Inc.b0d302c2-58a0-4c3e-9c4a-fd34de40c0342026-06-15Warnings, Adverse reactionsExact identifier
unii: ND2M416302
SFL SUNSCREEN - SOL DEFENSE SPF 30TITANIUM DIOXIDE, ZINC OXIDELifeline Medical, Inc5438c185-31c9-c51e-e063-6394a90ae9ef2026-06-14WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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