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 113 of 117 · 2,323 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Latte	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	32d99955-1593-426b-958e-5dcf689192a3	2021-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Tawny	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	762deb57-754b-46a9-9907-de05e11da178	2021-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Amber	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	3b5366e4-180a-4b98-9524-63601ae9d270	2021-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cool Vanilla	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	9a0ab557-e1f3-4c89-a9ae-0f81fbc5032e	2021-11-04	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Calico	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	3e67abb5-84a4-4a78-9ea3-9fd57cbeb482	2021-11-04	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cool Ivory	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	477d79c1-f169-4d0e-a95d-f5e832855f0d	2021-11-04	Warnings	Exact identifier unii: 15FIX9V2JP
Anhydrous SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Owen Biosciences, Inc.	1510cae2-9c8f-45ba-b088-67747af3d30c	2021-07-15	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Tawny	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	3f0480e4-b2c3-962c-e063-6294a90a4f23	2021-07-13	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Cool Ivory	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	aa708db4-ad90-49b7-a250-5698e4c7d3d6	2021-07-13	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Calico	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	96437795-906f-4e11-ac69-c0c2ae264aae	2021-07-13	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Cashew	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	b5527aba-5856-44cd-a1d5-f2d7cefb45ea	2021-07-13	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Warm Ivory	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	9b641ccb-3046-4b21-8164-b80813090cb4	2021-07-13	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Deeply Beige	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	2500fe73-00e2-47ba-9e2b-1c268ed4a9e6	2021-07-13	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Bamboo	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	4df1b021-5028-456e-87f2-a96ea6c26c7b	2021-07-13	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Cedar	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	830a485c-53d4-4fa9-b0cd-0fd2a9bd234b	2021-07-13	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Deeply Honey	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	8a9fe755-32a2-49b0-8c78-f84bd2ba148f	2021-07-13	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Honey	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	c5f3f1bc-adca-495f-b1bc-51c91d42a480	2021-07-13	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Uber	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	64db3a1f-d6c7-4766-a52c-a4b0c39e2633	2021-07-13	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Walnut	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	582a8244-dab8-4861-9115-2e895a586fb9	2021-07-13	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Deeply Bronze	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	377405a6-b6c6-4afb-9270-73d933029054	2021-07-13	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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