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
Label	Manufacturer	Effective date	Type
BELBUCA - BioDelivery Sciences International Inc	BioDelivery Sciences International Inc	2026-01-02	HUMAN PRESCRIPTION DRUG LABEL
BELBUCA - Quality Care Products, LLC	Quality Care Products, LLC	2021-04-16	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
59385-024-60	2021-07-29	C162847	48780-1	c7ccaba7-10fb-fd44-e053-dadaa90aa01b	These 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
59385-024-60	2021-07-23	C162847	48780-1	c7ccaba7-10fb-fd44-e053-dadaa90aa01b	These 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 NDC	Product	Description	Form	Quantity	Strength	SPL version
59385-024-01	BELBUCA	1 in 1 POUCH	FILM, SOLUBLE	1		18
59385-024-60	BELBUCA	60 in 1 CARTON	FILM, SOLUBLE	60		18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59385-024	BELBUCA (BUPRENORPHINE HYDROCHLORIDE) FILM, SOLUBLE [BIODELIVERY SCIENCES INTERNATIONAL INC]	17	Current NDC, Legacy NDC, 2 package rows	20240104_bc2b7a3d-72cf-497c-95b0-ba2b71f63c64.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59385-024-01	EA - Each	59385-024	58da261f-fb32-4653-afc9-cd5a11fcec3e	1	2018-03-08
59385-024-60	EA - Each	59385-024	48a6908f-f6e2-4964-8a50-9b4b52e84324	1	2017-09-11

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 116 of 118 · 2,352 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Latte	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	e66734e4-34e7-4674-bb98-bdca931a176d	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Sand	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	bf78f7a7-93ca-425e-8571-175da6798e8e	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Sepia	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	418cdd4a-23f7-4181-b734-5ab7456494a2	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Toffee	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	50138c51-f424-4b07-b3eb-c0d31d8ecf16	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 Cameo	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	01a861b9-0ab6-4c4c-a407-428a64509a1c	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 Birch	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	d5431d62-fded-4cdc-81a1-5b5e3eb92873	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 Tawny	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	52c3378f-6b99-42fa-900e-8a693864c615	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
CO COOL	MENTHOL, PEPPERMINT OIL, PINUS PUMILIO BRANCH/LEAF OIL	Lydia Co., Ltd.	90b213fe-f7b9-555c-e053-2a95a90a1df3	2021-06-27	Warnings	Exact identifier unii: AV092KU4JH
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	ee831456-5962-4d5e-ad0c-69ab85860453	2020-06-03		Exact identifier unii: XF417D3PSL
Renacidin	CITRIC ACID, GLUCONOLACTONE AND MAGNESIUM CARBONATE	United-Guardian, Inc.	13a9bbba-db21-4cba-991c-5d8afaf2ed74	2019-12-17	Warnings, Adverse reactions	Exact identifier unii: XF417D3PSL
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	e41adb4e-06fb-4141-ba55-50b043f3c9da	2019-11-19		Exact identifier unii: XF417D3PSL
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	14445dfd-6041-40cd-a043-3f4da6bcb9c1	2019-11-18		Exact identifier unii: XF417D3PSL
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	2557199a-5f60-49d8-b093-1e0700211243	2019-11-18		Exact identifier unii: XF417D3PSL
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	794f724c-87f0-49c1-9b26-c9e491978313	2019-11-18		Exact identifier unii: XF417D3PSL
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	5c7d3287-883a-459b-9214-074a583c8a59	2019-11-18		Exact identifier unii: XF417D3PSL
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	448a1dc5-7a98-4b2f-82af-4b92de05cfc3	2019-11-18		Exact identifier unii: XF417D3PSL
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Cool Vanilla	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	d701c221-9f68-47ff-b766-2f4f1998649f	2019-10-08	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Amber	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	7f5e6872-4d26-410e-8afe-16a016f9a399	2019-10-08	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Advanced All in One Foundation SPF 50 Warm Ivory	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	1124ba7d-a328-409b-8c88-e74bb3e501f5	2019-10-08	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Advanced All in One Foundation SPF 50 Honey	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	9c407dc7-fcde-4660-9a06-57bd8a6b867d	2019-10-08	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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