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 129 of 283 · 5,656 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EO Hand Sanitizer Wipes LavenderALCOHOLEO Products, LLC1a8cb031-5608-400f-b924-feb6bbd17fa12025-12-09WarningsExact identifier
unii: 3K9958V90M
PaxLyteLEUCOVORIN, FOLIC ACID, LEVOMEFOLATE MAGNESIUM, FERROUS CYSTEINE GLYCINATE, 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, PHOSPHATIDYL SERINE, PYRIDOXAL 5-PHOSPHATE, FLAVIN ADENINE DINUCLEOTIDE, NADH, COBAMAMIDE, COCARBOXYLASE (THIAMINE PYROPHOSPHATE), MAGNESIUM ASCORBATE, ZINC ASCORBATE, MAGNESIUM L-THREONATE AND BETAINE CAPSULEJaymac Pharmaceuticalsf520b130-61b3-443e-aaf6-91e094e7a3342025-12-08Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Skin Filter Matte SPFTITANIUM DIOXIDE, ZINC OXIDEMALORIE MILES3647f983-9e75-8955-e063-6294a90af1622025-12-08Exact identifier
unii: 15FIX9V2JP
Skin Filter Matte SPFTITANIUM DIOXIDE, ZINC OXIDEMALORIE MILES3649f758-e31b-3c6a-e063-6294a90a5c362025-12-08Exact identifier
unii: 15FIX9V2JP
Matte Shield SPFTITANIUM DIOXIDE, ZINC OXIDEACNE SOLUTIONS NYC INC3bb582ec-71e7-4ad8-e063-6394a90a94d42025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Mineral Based Sunscreen Stick Non-TintedTITANIUM DIOXIDE, ZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION3245561d-a90c-7bf0-e063-6394a90ab3b62025-12-08Exact identifier
unii: 15FIX9V2JP
Mineral Based Sunscreen Stick TintedTITANIUM DIOXIDE, ZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION3245c1f7-2c1b-b6ad-e063-6394a90aaee62025-12-08Exact identifier
unii: 15FIX9V2JP
Mineral Based Foam Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION32465271-abb9-d03f-e063-6294a90a990e2025-12-08Exact identifier
unii: 15FIX9V2JP
Mineral Based Foam Sunscreen Non-TintedTITANIUM DIOXIDE, ZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION32486bfb-0cc8-0283-e063-6394a90a99672025-12-08Exact identifier
unii: 15FIX9V2JP
Snap Labs Ammonia InhalantsAMMONIA INHALANTBrined LLC d/b/a Snap Labs453b0e9c-8676-99fa-e063-6394a90a88a12025-12-08WarningsExact identifier
unii: 5138Q19F1X
Snap Labs 20-Count Ammonia InhalantsAMMONIA INHALANTSBrined LLC d/b/a Snap Labs4575d816-b08f-13fb-e063-6294a90af3ba2025-12-08WarningsExact identifier
unii: 5138Q19F1X
Healthy Mineral Sunscreen No Shine - No TintTITANIUM DIOXIDE, ZINC OXIDEZen Dermatology, Inc.31572a16-5f60-565f-e063-6394a90ab8c92025-12-08WarningsExact identifier
unii: 15FIX9V2JP
AcneFix Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEACNEFIX INC.315894b7-ac1b-0982-e063-6294a90ab8792025-12-08Exact identifier
unii: 15FIX9V2JP
Shunly Natural Cover SPF50TITANIUM DIOXIDE, ZINC OXIDEShunly Skin Carea64e373b-b3f6-4024-b5f5-253783485cd62025-12-08WarningsExact identifier
unii: 15FIX9V2JP
AcneFix Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEACNEFIX INC.31583c7e-365a-d899-e063-6394a90aa63f2025-12-08Exact identifier
unii: 15FIX9V2JP
Mineral Fusion TintedTITANIUM DIOXIDE, ZINC OXIDEFOREFRONT DERMATOLOGY, S.C.334ec844-5560-50f7-e063-6394a90a01be2025-12-08Exact identifier
unii: 15FIX9V2JP
Mineral Fusion TintedTITANIUM DIOXIDE, ZINC OXIDEFOREFRONT DERMATOLOGY, S.C.334f90d6-68e5-db37-e063-6294a90a5fb12025-12-08Exact identifier
unii: 15FIX9V2JP
Silk ScreenTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c44baf4-9555-faad-e063-6294a90ab24f2025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Glow StickTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c54b857-c017-a953-e063-6394a90a38df2025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Lip ShieldTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c545e55-3f55-842b-e063-6394a90ae48e2025-12-08WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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