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 112 of 118 · 2,352 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lipotox	SQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM,	BioActive Nutritional, Inc.	a1538692-ca00-4e52-9b7e-409767ee27e1	2023-09-05	Warnings	Exact identifier unii: OJ245FE5EU unii: Z8IX2SC1OH unii: 15FIX9V2JP unii: A2I8C7HI9T
Anubis Barcelona	PEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ALLANTOIN	ANUBIS COSMETICS SL	eb9244ea-6102-3cbe-e053-2a95a90ab8f6	2023-09-01	Warnings	Exact identifier unii: 6DC9Q167V3 unii: Z8IX2SC1OH unii: A2I8C7HI9T
Anubis Barcelona Regul Oil	PROPYLENE GLYCOL, PANTHENOL, THIAMINE HCL	ANUBIS COSMETICS SL	eb8e5beb-4452-58c2-e053-2a95a90a66e0	2023-09-01	Warnings	Exact identifier unii: 6DC9Q167V3 unii: A2I8C7HI9T
Anubis Barcelona Protective Line	ETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENE	ANUBIS COSMETICS SL	ec83846f-11c0-8f59-e053-2995a90ab9d2	2023-09-01	Warnings	Exact identifier unii: 6DC9Q167V3 unii: 15FIX9V2JP
Anubis Barcelona Regul Oil	CETEARYL ETHYLHEXANOATE, PROPYLENE GLYCOL, GLYCERYL STEARATE SE	ANUBIS COSMETICS SL	eb68c3ab-7835-1a1c-e053-2995a90a0d66	2023-09-01	Warnings	Exact identifier unii: 6DC9Q167V3 unii: Z8IX2SC1OH unii: A2I8C7HI9T
Anubis Barcelona Spa Line	ORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACID	ANUBIS COSMETICS SL	eb01a962-ab38-18ec-e053-2995a90acdeb	2023-09-01	Warnings	Exact identifier unii: 6DC9Q167V3 unii: 15FIX9V2JP
Anubis Barcelona Regul OIl	PEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ARCTIUM MAJUS ROOT EXTRACT	ANUBIS COSMETICS SL	eb905bd0-c600-b8b2-e053-2995a90ad259	2023-09-01	Warnings	Exact identifier unii: 6DC9Q167V3 unii: Z8IX2SC1OH unii: A2I8C7HI9T
Anubis Barcelona Regul Oil	PROPYLENE GLYCOL, GLYCERYL STEARATE SE, HUMULUS LUPULUS (HOPS) CONE EXTRACT	ANUBIS COSMETICS SL	eb7c418b-8bee-26a3-e053-2a95a90a4e96	2023-09-01	Warnings	Exact identifier unii: 6DC9Q167V3 unii: Z8IX2SC1OH unii: A2I8C7HI9T
Anubis Barcelona New Even	LACTIC ACID, CITRIC ACID, GLYCOLIC ACID	ANUBIS COSMETICS SL	eaeeb6e0-5322-20c4-e053-2995a90a9fd9	2023-09-01	Warnings	Exact identifier unii: 6DC9Q167V3
Liverex I	GINKGO BILOBA, FEL TAURI, GALLBLADDER (SUIS), HEPAR SUIS), THYROIDINUM (SUIS), GERMANIUM SESQUIOXIDE, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALICUM ACIDUM, MANGANUM METALLICUM, PYRUVIC ACID, SUCCINICUM ACIDUM, NAPHTHOCHINONUM, ARSENICUM METALLICUM, SULPHUR, ACONITICUM ACIDUM, CIS, LYCOPODIUM CLAVATUM, NATRUM OXALACETICUM, PHOSPHORUS	Energique, Inc.	1c23c489-0a43-4736-a30a-0ae02c09fb45	2023-07-21	Warnings	Exact identifier unii: XF417D3PSL
REFL HS	ADENOSINUM TRIPHOSPHORICUM DINATRUM, NADIDUM, ARGENTUM NITRICUM, IPECACUANHA, ROBINIA PSEUDOACACIA, SULPHUR, ORIGANUM VULGARE, DUODENUM (SUIS), ESOPHAGUS (SUIS), FUNICULUS UMBILICALIS SUIS, STOMACH (SUIS), NUX VOMICA, COUMARINUM, ERYTHRAEA CENTAURIUM, PANCREATINUM, MURIATICUM ACIDUM, CITRICUM ACIDUM, FORMICUM ACIDUM, SARCOLACTICUM ACIDUM, COENZYME A, PROTEUS (MORGANI)	Deseret Biologicals, Inc.	2fe2d3c1-1829-4a33-be8e-2bad52546f36	2023-07-17	Warnings	Exact identifier unii: XF417D3PSL
Household Antigens	ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR	BioActive Nutritional	3382df85-3ec5-4371-830e-4ed345b8f51b	2023-07-14	Warnings	Exact identifier unii: 6DC9Q167V3
Pneumotox	TRITICUM AESTIVUM, ALFALFA, ARNICA MONTANA, ASCLEPIAS TUBEROSA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, FUCUS VESICULOSUS, HORDEUM VULGARE, IODIUM, NASTURTIUM AQUATICUM, PLANTAGO MAJOR, RAPHANUS SATIVUS, TRIFOLIUM PRATENSE, TRIGONELLA FOENUM-GRAECUM, SYMPHYTUM OFFICINALE, LUNG (SUIS), ORYZA SATIVA, SILICEA, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, NATRUM MURIATICUM, NITRICUM ACIDUM,	BioActive Nutritional, Inc.	f8846fb1-92e5-4f8e-b3b3-bc620df90a62	2023-07-12	Warnings	Exact identifier unii: 6DC9Q167V3
SODIUM PHENYLACETATE AND SODIUM BENZOATE	SODIUM PHENYLACETATE AND SODIUM BENZOATE	MAIA PHARMACEUTICALS, INC	3529be10-0004-4628-9ca1-67a8acd86b51	2023-07-05	Warnings, Adverse reactions	Exact identifier unii: OJ245FE5EU
Sheer Tint Mineral Sunscreen Broad Spectrum SPF 50 - Light/Medium Shade	SPF 50 SUNSCREEN BROAD SPECTRUM - LIGHT/MEDIUM SHADE	Autumn Harp	fd6807e1-c8c0-b361-e053-6294a90aea0c	2023-06-05	Warnings	Exact identifier unii: 15FIX9V2JP
LY-CO	ANGELICA ARCHANGELICA, KALI MURIATICUM, YUCCA FILAMENTOSA, CARTILAGO SUIS, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, RHUS TOX, CAUSTICUM, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, OXALICUM ACIDUM, ARNICA MONTANA, BORRELIA BURGDORFERI NOSODE, LATRODECTUS MACTANS, CITRICUM ACIDUM, CYTOMEGALOVIRUS NOSODE, RICKETTSIA NOSODE (RICKETTSIA PROWAZEKII), CHLAMYDIA TRACHOMATIS, LEDUM PALUSTRE	Bhp Holdings, Inc.	47140966-5b49-432d-bf35-bcae14f42082	2023-06-01	Warnings	Exact identifier unii: XF417D3PSL
Lyme and Co-Infection Nosode	ANGELICA ARCHANGELICA, KALI MURIATICUM, YUCCA FILAMENTOSA, CARTILAGO SUIS, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, RHUS TOX, CAUSTICUM, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, OXALICUM ACIDUM, ARNICA MONTANA, BABESIA MICROTI, BORRELIA BURGDORFERI NOSODE, LATRODECTUS MACTANS, CITRICUM ACIDUM, CYTOMEGALOVIRUS NOSODE, RICKETTSIA NOSODE (RICKETTSIA PROWAZEKII), CHLAMYDIA TRACHOMATIS, LEDUM PALUSTRE	Bhp Holdings, Inc.	f6186157-256f-4454-b122-f7665e3286f4	2023-06-01	Warnings	Exact identifier unii: XF417D3PSL
Thinksport Mineral SPF 50	ZINC OXIDE AND TITANIUM DIOXIDE	thinkOperations,LLC	77b63c0b-353b-4f5f-95c7-6f7eeab81471	2023-05-30	Warnings	Exact identifier unii: 15FIX9V2JP
Think Kids Mineral SPF 50	ZINC OXIDE AND TITANIUM DIOXIDE	thinkOperations,LLC	25c59820-a08d-4abe-87ae-a787ac8b2ac2	2023-05-30	Warnings	Exact identifier unii: 15FIX9V2JP
BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE	Accord Healthcare, Inc	35d29e9b-9950-452a-a795-5a7514f0edfd	2023-05-03	Warnings, Adverse reactions	Exact identifier unii: 56W8MW3EN1

Reported adverse events (FAERS/openFDA)#

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