NDC 59385-026-01 - 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: 59385-026
Requested NDC: 59385-026-01
Package NDCs from labels: 59385-026-01, 59385-026-60
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
59385-026-60	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
59385-026-60	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
59385-026-01	BELBUCA	1 in 1 POUCH	FILM, SOLUBLE	1		18
59385-026-60	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
59385-026	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
59385-026-01	EA - Each	59385-026	e9c73833-fdd2-4d60-a383-b00a9a3748b2	1	2018-02-20
59385-026-60	EA - Each	59385-026	3d01cbcf-badc-45d2-8e37-8b52cbfcae4d	1	2018-02-20

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 86 of 117 · 2,323 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kroger Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Kroger Company	6d858b0e-a3c8-2686-e053-2991aa0acc06	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL
TopCare Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Topco Associates LLC	639f9d57-f26a-708a-e053-2a91aa0a6962	2024-11-13	Warnings, Adverse reactions	Exact identifier unii: XF417D3PSL
Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	H. E. Butt Grocery Company	6418cde9-607b-4ca1-e053-2991aa0a9170	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL
Bromo Seltzer	ASPIRIN, SODIUM BICARBONATE, CITRIC ACID	Tower Laboratories Ltd	8ff88ee1-e33e-4051-992f-24e2720c48ce	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL
Care One Original Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Foodhold U.S.A.	8f662c51-d2fa-6458-e053-2995a90ac6fd	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL
Top Value Effervescent Pain Relief	APIRIN, CITRIC ACID, SODIUM BICARBONATE	Tower Laboratories Ltd	43c7f435-735c-3fab-e054-00144ff88e88	2024-11-13	Warnings, Adverse reactions	Exact identifier unii: XF417D3PSL
DG Health Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	DOLGENCORP, INC	8f1343d5-2884-3a14-e053-2a95a90a2f90	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL
Good Sense Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Good Sense	cd25b0c3-0134-beef-e053-2a95a90a092b	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL
Drug Mart Effervescent Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Discount Drug Mart, Inc	8bc65603-1dbf-30ab-e053-2995a90a7c15	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL
Best Choice Effervescent Antacid Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Valu Merchandisers Company	8aab905b-5fe7-dddb-e053-2995a90a6c6f	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL
Publix Fast Relief Effervescent	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Publix Super Markets Inc.	73051f16-2569-7394-e053-2991aa0a5359	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL
Quality Choice Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Chain Drug Marketing Association	70d265de-ff94-e0e4-e053-2a91aa0a962a	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL
Quality Choice Extra Strength Effervescent Antacid and Pain Relief	ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE	Chain Drug Marketing Association	9f7d0c96-a561-a8a0-e053-2995a90a250b	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL
WinCo Foods Effervescent Antacid and Pain Relief	ASPIRIN, SODIUM BICARBONATE, CITRIC ACID TABLET	WinCo Foods, LLC	0c8a755a-089f-477f-97e9-0dd6fdfbe99d	2024-11-13	Warnings	Exact identifier unii: XF417D3PSL
Neutrogena Ultra Sheer Dry-Touch Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Kenvue Brands LLC	18e40353-5c95-4d64-e063-6394a90a017c	2024-11-12	Warnings	Exact identifier unii: 15FIX9V2JP
Neutrogena Healthy Skin Liquid Makeup SPF 20 - Classic Ivory 10	TITANIUM DIOXIDE	Kenvue Brands LLC	e0ed4537-8146-45e8-e053-2995a90ac51b	2024-11-12	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4.5W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	504d8118-f84d-4f3f-abd1-463f3780a2cb	2024-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2WO	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	0d4e667a-cf93-4f6d-8565-ecfa9a18cfbf	2024-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2.5W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	cb1d643e-34dc-48f2-aecd-ba2a35dc3403	2024-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	097b3d7b-5dff-4206-99f1-6573902232e9	2024-11-11	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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