FDA.reportPublic FDA data

NDC 59385-024-01 - BELBUCA

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
59385-024
Requested NDC
59385-024-01
Package NDCs from labels
59385-024-01, 59385-024-60
Manufacturer
BioDelivery Sciences International Inc
Effective date
2026-01-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
BELBUCA - BioDelivery Sciences International IncBioDelivery Sciences International Inc2026-01-02HUMAN PRESCRIPTION DRUG LABEL
BELBUCA - Quality Care Products, LLCQuality Care Products, LLC2021-04-16HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59385-024-602021-07-29C16284748780-1c7ccaba7-10fb-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use BELBUCA safely and effectively. See full prescribing information for BELBUCA. BELBUCA ® (buprenorphine buccal film), CIII Initial U.S. Approval: 1981
59385-024-602021-07-23C16284748780-1c7ccaba7-10fb-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use BELBUCA safely and effectively. See full prescribing information for BELBUCA. BELBUCA ® (buprenorphine buccal film), CIII Initial U.S. Approval: 1981

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59385-024-01BELBUCA1 in 1 POUCHFILM, SOLUBLE118
59385-024-60BELBUCA60 in 1 CARTONFILM, SOLUBLE6018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59385-024BELBUCA (BUPRENORPHINE HYDROCHLORIDE) FILM, SOLUBLE [BIODELIVERY SCIENCES INTERNATIONAL INC]17Current NDC, Legacy NDC, 2 package rows20240104_bc2b7a3d-72cf-497c-95b0-ba2b71f63c64.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59385-024-01EA - Each59385-02458da261f-fb32-4653-afc9-cd5a11fcec3e12018-03-08
59385-024-60EA - Each59385-02448a6908f-f6e2-4964-8a50-9b4b52e8432412017-09-11

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 81 of 118 · 2,352 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kids SPF50Plus Mineral Sunscreen Rollerball Totally TropicalZINC OXIDE AND TITANIUM DIOXIDEKAS Direct LLC dba BabyGanicsd3bdda65-bcb4-42d9-84af-d14c7f4421bd2024-12-23WarningsExact identifier
unii: 15FIX9V2JP
Kids SPF50 Plus Mineral Sunscreen Continuous Totally TropicalZINC OXIDE AND TITANIUM DIOXIDEKAS Direct LLC dba BabyGanicsd5ffe993-de8f-4623-a010-9cb8dd70de072024-12-23WarningsExact identifier
unii: 15FIX9V2JP
CERAVE Hydrating Mineral Sunscreen Light Sheer Tint Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inc8b298516-70df-47ab-834f-51dcde28a43a2024-12-23WarningsExact identifier
unii: 15FIX9V2JP
Lancome Paris Renergie Lift Makeup Broad Spectrum SPF 27 SunscreenOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE6a14ee23-28c9-4704-8af9-d1c4db0d92562024-12-23WarningsExact identifier
unii: 15FIX9V2JP
EcoStick Sunscreen SPF 35ZINC OXIDE, TITANIUM DIOXIDEStream2Sea, LLCeba17b7a-5e96-4462-9b71-44c2bc577dce2024-12-21WarningsExact identifier
unii: 15FIX9V2JP
Planet Protecting Sunscreen 30TITANIUM DIOXIDEStream2Sea, LLC89e44c5f-121e-4fdd-b9e0-023909ea32f52024-12-21WarningsExact identifier
unii: 15FIX9V2JP
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PROPYLPARABEN, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR, PARAFFINUMEnergique, Inc.f3db63df-62a4-48d6-92e7-94e4a57015522024-12-20WarningsExact identifier
unii: 6DC9Q167V3
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Face Reality mineral matte spf 28 Sunscreen SPF 28ZINC OXIDE, TITANIUM DIOXIDEFace Reality, LLC29b70afe-cf9d-d0ba-e063-6394a90a1cc42024-12-20WarningsExact identifier
unii: 15FIX9V2JP
Oars and Alps SPF 50 100% Mineral Antioxidant SunscreenTITANIUM DIOXIDE, ZINC OXIDEOars and Alps LLCf3971b85-a13e-4195-e053-2995a90a73cb2024-12-20WarningsExact identifier
unii: 15FIX9V2JP
Carpe SPF 30 Face PrimerTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc. DBA Carpefeac5ee2-faa5-fd17-e053-6394a90a7f992024-12-20WarningsExact identifier
unii: 15FIX9V2JP
Nuria Defend Matte Finish Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDESmall World Brandsb1df4c81-333b-450d-963e-6670ab9bbda92024-12-20WarningsExact identifier
unii: 15FIX9V2JP
foundcealer multi-tasking foundation Broad Spectrum SPF 20 Sunscreen 8B porcelain beigeTITANIUM DIOXIDE AND ZINC OXIDETarte, Inc.062fa0d9-f384-48af-8269-42de3a788db12024-12-20WarningsExact identifier
unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 PORCELAINOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299ac9a5-f609-d804-e063-6394a90abd052024-12-19WarningsExact identifier
unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 IVORYOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299ad424-16a8-66b1-e063-6394a90a07532024-12-19WarningsExact identifier
unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 NUDEOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299afef9-758f-74e1-e063-6294a90a80722024-12-19WarningsExact identifier
unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 NATURAL BEIGEOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299b3276-7973-d33f-e063-6294a90a6ce12024-12-19WarningsExact identifier
unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 CLASSIC TANOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299afe24-d496-5745-e063-6394a90aa1b32024-12-19WarningsExact identifier
unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 WARM BEIGEOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299b1f9a-34fd-cb50-e063-6394a90af9252024-12-19WarningsExact identifier
unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 SOFT SANDOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299b3236-3f3d-c9e8-e063-6394a90a74432024-12-19WarningsExact identifier
unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 TAWNYOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299b416d-ce02-3462-e063-6294a90a38f02024-12-19WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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