FDA.reportPublic FDA data

NDC 59385-022-01 - 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
59385-022
Requested NDC
59385-022-01
Package NDCs from labels
59385-022-01, 59385-022-60
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
59385-022-602021-07-29C16284748780-1c7ccaba7-10fb-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
59385-022-602021-07-23C16284748780-1c7ccaba7-10fb-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
59385-022-01BELBUCA1 in 1 POUCHFILM, SOLUBLE118
59385-022-60BELBUCA60 in 1 CARTONFILM, SOLUBLE6018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59385-022BELBUCA (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
59385-022-01EA - Each59385-022be85e160-d44c-4535-93fa-bf0b62e4b39b12018-03-08
59385-022-60EA - Each59385-02253a7aa98-d3f5-4707-b927-0dabae64c9e512017-11-06

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 26 of 117 · 2,323 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buprenorphine HCl and Naloxone HClBUPRENORPHINE AND NALOXONEAvPAKb955054b-b37d-4079-4fed-5939b763ecb42026-01-08Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Anhydrous SPF 30TITANIUM DIOXIDE, ZINC OXIDEOwen Biosciences, Inc.0cc8221d-5ec5-4abf-a4f5-ab06e8dcea682026-01-08WarningsExact identifier
unii: 15FIX9V2JP
CitraNatal 90 DHAVITAMIN C, CALCIUM, IRON, VITAMIN D3, VITAMIN E, THIAMIN, RIBOFLAVIN, NIACINAMIDE, VITAMIN B6, FOLIC ACID, IODINE, ZINC, COPPER, DOCUSATE SODIUMMission Pharmacal Company81e639d7-352e-4eaa-87d9-582da68b97282026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9E8X80D2L0
HM-B (EDIBLE VINEGAR)TITANIUM OXIDEDEMAND SERVICE, CO., LTD.9a7b1e74-b8af-449c-e053-2995a90a349e2026-01-08WarningsExact identifier
unii: 15FIX9V2JP
Cell Energy Performance Drops 2048CELL ENERGY PERFORMANCE DROPSProfessional Complementary Health Formulas8701ea61-5d5f-466b-8d2c-f808e7b4d8fe2026-01-08WarningsExact identifier
unii: XF417D3PSL
Metab 6012METABProfessional Complementary Health Formulasf3576d6f-c9ab-4370-8a32-b6c4bf6ba4fd2026-01-08WarningsExact identifier
unii: XF417D3PSL
Herbal Diuretic Liquescence 3011HERBAL DIURETIC LIQUESCENCEProfessional Complementary Health Formulas5eee7f21-a3c4-46e0-a642-a4ca635734e32026-01-08WarningsExact identifier
unii: XF417D3PSL
Hawaiian Blend Extreme Zinc SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Islander Group4084dd98-357f-4011-b0d4-db6536d2931f2026-01-07WarningsExact identifier
unii: 15FIX9V2JP
Hawaiian Blend Extreme Zinc SPF 50ZINC OXIDE, TITANIUM DIOXIDEThe Islander Group9b4acc5e-fdaf-4fcb-83a9-69e430dd43de2026-01-07WarningsExact identifier
unii: 15FIX9V2JP
Hawaiian Blend Sensitive Zinc SPF 50ZINC OXIDE, TITANIUM DIOXIDEThe Islander Groupb42261c5-fa6e-4bb3-93c0-97032ab9f7162026-01-07WarningsExact identifier
unii: 15FIX9V2JP
BETA-GLUCAN MILD SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEIUNIK Co., Ltd47d6ad8b-1081-ee21-e063-6294a90a0e632026-01-07WarningsExact identifier
unii: 15FIX9V2JP
Solar Swipe Mineral Sunscreen SPF50SOLAR SWIPE MINERAL SUNSCREEN SPF50Guangzhou Fantesy Biotechnology Co.,Ltd47d75d61-5295-3eab-e063-6394a90a01c12026-01-07WarningsExact identifier
unii: 15FIX9V2JP
Hawaiian Blend Essential Zinc SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Islander Group5a6e622f-2c00-406a-8860-d7081656f5972026-01-06WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO SYNCHRO SKIN LASTING Liquid FOUNDATION Neutral 5OCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION66c22f17-5418-42ff-97b2-33fa10f5eac32026-01-06WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO FUTURE Solution LX INFINITE TREATMENT PRIMERTITANIUM DIOXIDE, OCTINOXATE, AND ENSULIZOLESHISEIDO AMERICAS CORPORATIONff088b0c-27c9-4ea8-bf94-6261378c71902026-01-06WarningsExact identifier
unii: 15FIX9V2JP
Drs. pharmacy sunscreen SPF 50 (physical filters)SUNSCREEN SPF 50OL PHARMA TECH LLC. (Drs. Pharmacy)31e976a2-0623-0dca-e063-6394a90a08da2026-01-06WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 115 Fair ShirakabaOCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION26151cf4-0fee-4a42-92fd-4d7b9cef83812026-01-06WarningsExact identifier
unii: 15FIX9V2JP
Drs. pharmacy sunscreen SPF 50 (physical filters)SUNSCREEN SPF 50OL PHARMA TECH LLC. (Drs. Pharmacy)315a5ca4-4536-d585-e063-6294a90a1c502026-01-06WarningsExact identifier
unii: 15FIX9V2JP
Drs. pharmacy sunscreen SPF 30 (Physical Filters)SUNSCREEN SPF 30OL PHARMA TECH LLC. (Drs. Pharmacy)315a5b1f-9dc2-a243-e063-6394a90a5e082026-01-06WarningsExact identifier
unii: 15FIX9V2JP
LING NEW YORK Save Face Broad Spectrum SPF 30LING NEW YORK SAVE FACE BROAD SPECTRUM SPF 30Guangzhou Fantesy Biotechnology Co.,Ltd1dfa80bd-495a-18fb-e063-6394a90a4d0d2026-01-05WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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