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
Label	Manufacturer	Effective date	Type
BELBUCA - BioDelivery Sciences International Inc	BioDelivery Sciences International Inc	2026-01-02	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
59385-021-60	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
59385-021-60	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
59385-021-01	BELBUCA	1 in 1 POUCH	FILM, SOLUBLE	1		18
59385-021-60	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
59385-021	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
59385-021-01	EA - Each	59385-021	b8b9a4da-a323-4f8a-b692-f4c63c2d2f11	1	2018-03-08
59385-021-60	EA - Each	59385-021	a260c1b5-0964-4a28-9447-c673d4ab5bf3	1	2017-10-13

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 117 of 117 · 2,323 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Renewal Firming Day Broad Spectrum SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	BURT'S BEES, INC.	18ceb5d8-4b76-6a54-e054-00144ff88e88	2015-06-18	Warnings	Exact identifier unii: 15FIX9V2JP
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	051f7347-5a76-4664-8fe2-e61b3dfcb0e4	2014-08-27		Exact identifier unii: XF417D3PSL
TiZO2	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD.	30468afc-9616-4765-b046-12e97a0a7827	2010-12-20	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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