FDA.reportPublic FDA data

NDC 59385-021-01 - 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
59385-021
Requested NDC
59385-021-01
Package NDCs from labels
59385-021-01, 59385-021-60
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59385-021-602021-07-29C16284748780-1c7ccaba7-10fb-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
59385-021-602021-07-23C16284748780-1c7ccaba7-10fb-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
59385-021-01BELBUCA1 in 1 POUCHFILM, SOLUBLE118
59385-021-60BELBUCA60 in 1 CARTONFILM, SOLUBLE6018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59385-021BELBUCA (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
59385-021-01EA - Each59385-021b8b9a4da-a323-4f8a-b692-f4c63c2d2f1112018-03-08
59385-021-60EA - Each59385-021a260c1b5-0964-4a28-9447-c673d4ab5bf312017-10-13

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 105 of 117 · 2,323 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 7NOCTISALATE, TITANIUM DIOXIDEGuerlainbfa2b2be-958c-439f-b363-2623df2b85012023-11-08WarningsExact identifier
unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 3NOCTISALATE, TITANIUM DIOXIDEGuerlain15f73322-0b27-4412-b368-84bc768f55e82023-11-08WarningsExact identifier
unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 2WOCTISALATE, TITANIUM DIOXIDEGuerlain51392fe6-fbbb-4ea9-a7aa-98e1711eaa5d2023-11-08WarningsExact identifier
unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 4NOCTISALATE, TITANIUM DIOXIDEGuerlainb70b8ffc-091a-4969-86a7-6c3e1b9b9d742023-11-08WarningsExact identifier
unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 3WOCTISALATE, TITANIUM DIOXIDEGuerlain15fe0429-720c-4975-953d-285aa7ee12ce2023-11-08WarningsExact identifier
unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 4WOCTISALATE, TITANIUM DIOXIDEGuerlain1a733548-75a4-41ec-8d8d-3e6e9aad52e02023-11-08WarningsExact identifier
unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 8NOCTISALATE, TITANIUM DIOXIDEGuerlainf43c867a-161f-47b7-b3d8-7f7e6c6728042023-11-08WarningsExact identifier
unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0COCTISALATE, TITANIUM DIOXIDEGuerlain0d75be99-7607-4964-bb6e-3c731644ab4e2023-11-08WarningsExact identifier
unii: 15FIX9V2JP
SANTO REMEDIOS Piel Eterna Radiance Sunscreen Primer SPF-42TITANIUM DIOXIDE, ZINC OXIDESANTO REMEDIO LLC82d210bc-b7ca-4d74-be58-85f175a750582023-11-06WarningsExact identifier
unii: 15FIX9V2JP
Mineral Sunscreen SPF-30TITANIUM DIOXIDE, ZINC OXIDENEWCO LLCfa3c73a3-0dfb-4673-822a-45d946dee2602023-11-06WarningsExact identifier
unii: 15FIX9V2JP
RADIANCE Silky Mineral Primer Sunscreen SPF-42 HONEYTITANIUM DIOXIDE, ZINC OXIDESANTO REMEDIO LLC867a88df-9a18-447f-8301-2ec91566302e2023-11-06WarningsExact identifier
unii: 15FIX9V2JP
KOVR All-Natural SPF-30 Moisturizing Sunscreen for MenTITANIUM DIOXIDE, ZINC OXIDEACTIVE LIFE INCbf766aab-a52d-41e8-a06a-f2e536d2219b2023-11-06WarningsExact identifier
unii: 15FIX9V2JP
PROJECT REEF SPF-50ZINC OXIDE, TITANIUM DIOXIDEProject Reef LLC6bcd470c-6994-4d28-8370-4cc9d68e1e782023-11-06WarningsExact identifier
unii: 15FIX9V2JP
BB OSKIN Broad Spectrum SPF-30TITANIUM DIOXIDE, OCTOCRYLENE, ZINC OXIDEO'Skin Studio NYd84cca38-b673-484e-aa25-df58d904d4d32023-11-06WarningsExact identifier
unii: 15FIX9V2JP
Aruba Aloe Sport Line Lip Balm Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEAruba Aloe Balm NV80461b6d-b1b7-4220-894d-8bd4259094742023-11-06WarningsExact identifier
unii: 15FIX9V2JP
Image Prevention Refiner Primer SPF50ZINC OXIDE, TITANIUM DIOXIDE SUNSCREENSwiss-American CDMO, LLC0e490f11-666c-420c-8c12-b45cd238ce472023-11-06WarningsExact identifier
unii: 15FIX9V2JP
Farmasi BB Beauty Balm Cream SPF 15- 01 LightTITANIUM DIOXIDEFarmasi US LLC97c1da03-b79c-46a3-a9f0-7aeb94ed66da2023-11-05WarningsExact identifier
unii: 15FIX9V2JP
Farmasi BB Beauty Balm Cream SPF 15- 04 Medium to TanTITANIUM DIOXIDEFarmasi US LLCdeee5784-c68b-4cd7-acbf-f64391a01bfc2023-11-05WarningsExact identifier
unii: 15FIX9V2JP
Farmasi BB Beauty Balm Cream SPF 15- 02 Light to MediumTITANIUM DIOXIDEFarmasi US LLCcef1a926-b7d4-47d6-957d-e3092e60970c2023-11-05WarningsExact identifier
unii: 15FIX9V2JP
Farmasi BB Beauty Balm Cream SPF 15- 06 DeepTITANIUM DIOXIDEFarmasi US LLC2f13a160-740f-4b09-8858-e438a9ba303e2023-11-05WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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