FDA.reportPublic FDA data

NDC 50419-524-01 - Betaseron

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
50419-524
Requested NDC
50419-524-01
Package NDCs from labels
50419-524-01, 50419-524-35, 50419-524-05, 50419-524-09, 50419-524-81
Manufacturer
Bayer HealthCare Pharmaceuticals Inc.
Effective date
2026-03-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Betaseron - Bayer HealthCare Pharmaceuticals Inc.Bayer HealthCare Pharmaceuticals Inc.2026-03-03HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50419-524-052024-08-20These highlights do not include all the information needed to use BETASERON safely and effectively. See full prescribing information for BETASERON. BETASERON (interferon beta-1b) for injection, for subcutaneous use Initial U.S. Approval: 1993
50419-524-052024-08-20These highlights do not include all the information needed to use BETASERON safely and effectively. See full prescribing information for BETASERON. BETASERON (interferon beta-1b) for injection, for subcutaneous use Initial U.S. Approval: 1993
50419-524-052024-08-20These highlights do not include all the information needed to use BETASERON safely and effectively. See full prescribing information for BETASERON. BETASERON (interferon beta-1b) for injection, for subcutaneous use Initial U.S. Approval: 1993
50419-524-092024-08-20These highlights do not include all the information needed to use BETASERON safely and effectively. See full prescribing information for BETASERON. BETASERON (interferon beta-1b) for injection, for subcutaneous use Initial U.S. Approval: 1993
50419-524-092024-08-20These highlights do not include all the information needed to use BETASERON safely and effectively. See full prescribing information for BETASERON. BETASERON (interferon beta-1b) for injection, for subcutaneous use Initial U.S. Approval: 1993
50419-524-092024-08-20These highlights do not include all the information needed to use BETASERON safely and effectively. See full prescribing information for BETASERON. BETASERON (interferon beta-1b) for injection, for subcutaneous use Initial U.S. Approval: 1993
50419-524-352024-08-20These highlights do not include all the information needed to use BETASERON safely and effectively. See full prescribing information for BETASERON. BETASERON (interferon beta-1b) for injection, for subcutaneous use Initial U.S. Approval: 1993
50419-524-352024-08-20These highlights do not include all the information needed to use BETASERON safely and effectively. See full prescribing information for BETASERON. BETASERON (interferon beta-1b) for injection, for subcutaneous use Initial U.S. Approval: 1993
50419-524-352024-08-20These highlights do not include all the information needed to use BETASERON safely and effectively. See full prescribing information for BETASERON. BETASERON (interferon beta-1b) for injection, for subcutaneous use Initial U.S. Approval: 1993
50419-524-812024-08-20These highlights do not include all the information needed to use BETASERON safely and effectively. See full prescribing information for BETASERON. BETASERON (interferon beta-1b) for injection, for subcutaneous use Initial U.S. Approval: 1993
50419-524-812024-08-20These highlights do not include all the information needed to use BETASERON safely and effectively. See full prescribing information for BETASERON. BETASERON (interferon beta-1b) for injection, for subcutaneous use Initial U.S. Approval: 1993
50419-524-812024-08-20These highlights do not include all the information needed to use BETASERON safely and effectively. See full prescribing information for BETASERON. BETASERON (interferon beta-1b) for injection, for subcutaneous use Initial U.S. Approval: 1993
50419-524-052024-07-30These highlights do not include all the information needed to use BETASERON safely and effectively. See full prescribing information for BETASERON. BETASERON (interferon beta-1b) for injection, for subcutaneous use Initial U.S. Approval: 1993
50419-524-052024-07-30These highlights do not include all the information needed to use BETASERON safely and effectively. See full prescribing information for BETASERON. BETASERON (interferon beta-1b) for injection, for subcutaneous use Initial U.S. Approval: 1993
50419-524-052024-07-30These highlights do not include all the information needed to use BETASERON safely and effectively. See full prescribing information for BETASERON. BETASERON (interferon beta-1b) for injection, for subcutaneous use Initial U.S. Approval: 1993
50419-524-092024-07-30These highlights do not include all the information needed to use BETASERON safely and effectively. See full prescribing information for BETASERON. BETASERON (interferon beta-1b) for injection, for subcutaneous use Initial U.S. Approval: 1993
50419-524-092024-07-30These highlights do not include all the information needed to use BETASERON safely and effectively. See full prescribing information for BETASERON. BETASERON (interferon beta-1b) for injection, for subcutaneous use Initial U.S. Approval: 1993
50419-524-092024-07-30These highlights do not include all the information needed to use BETASERON safely and effectively. See full prescribing information for BETASERON. BETASERON (interferon beta-1b) for injection, for subcutaneous use Initial U.S. Approval: 1993
50419-524-352024-07-30These highlights do not include all the information needed to use BETASERON safely and effectively. See full prescribing information for BETASERON. BETASERON (interferon beta-1b) for injection, for subcutaneous use Initial U.S. Approval: 1993
50419-524-352024-07-30These highlights do not include all the information needed to use BETASERON safely and effectively. See full prescribing information for BETASERON. BETASERON (interferon beta-1b) for injection, for subcutaneous use Initial U.S. Approval: 1993
50419-524-352024-07-30These highlights do not include all the information needed to use BETASERON safely and effectively. See full prescribing information for BETASERON. BETASERON (interferon beta-1b) for injection, for subcutaneous use Initial U.S. Approval: 1993
50419-524-812024-07-30These highlights do not include all the information needed to use BETASERON safely and effectively. See full prescribing information for BETASERON. BETASERON (interferon beta-1b) for injection, for subcutaneous use Initial U.S. Approval: 1993
50419-524-812024-07-30These highlights do not include all the information needed to use BETASERON safely and effectively. See full prescribing information for BETASERON. BETASERON (interferon beta-1b) for injection, for subcutaneous use Initial U.S. Approval: 1993
50419-524-812024-07-30These highlights do not include all the information needed to use BETASERON safely and effectively. See full prescribing information for BETASERON. BETASERON (interferon beta-1b) for injection, for subcutaneous use Initial U.S. Approval: 1993
50419-524-052024-01-30These highlights do not include all the information needed to use BETASERON safely and effectively. See full prescribing information for BETASERON. BETASERON (interferon beta-1b) for injection, for subcutaneous use Initial U.S. Approval: 1993
50419-524-052024-01-30These highlights do not include all the information needed to use BETASERON safely and effectively. See full prescribing information for BETASERON. BETASERON (interferon beta-1b) for injection, for subcutaneous use Initial U.S. Approval: 1993
50419-524-052024-01-30These highlights do not include all the information needed to use BETASERON safely and effectively. See full prescribing information for BETASERON. BETASERON (interferon beta-1b) for injection, for subcutaneous use Initial U.S. Approval: 1993
50419-524-092024-01-30These highlights do not include all the information needed to use BETASERON safely and effectively. See full prescribing information for BETASERON. BETASERON (interferon beta-1b) for injection, for subcutaneous use Initial U.S. Approval: 1993
50419-524-092024-01-30These highlights do not include all the information needed to use BETASERON safely and effectively. See full prescribing information for BETASERON. BETASERON (interferon beta-1b) for injection, for subcutaneous use Initial U.S. Approval: 1993
50419-524-092024-01-30These highlights do not include all the information needed to use BETASERON safely and effectively. See full prescribing information for BETASERON. BETASERON (interferon beta-1b) for injection, for subcutaneous use Initial U.S. Approval: 1993
50419-524-352024-01-30These highlights do not include all the information needed to use BETASERON safely and effectively. See full prescribing information for BETASERON. BETASERON (interferon beta-1b) for injection, for subcutaneous use Initial U.S. Approval: 1993
50419-524-352024-01-30These highlights do not include all the information needed to use BETASERON safely and effectively. See full prescribing information for BETASERON. BETASERON (interferon beta-1b) for injection, for subcutaneous use Initial U.S. Approval: 1993
50419-524-352024-01-30These highlights do not include all the information needed to use BETASERON safely and effectively. See full prescribing information for BETASERON. BETASERON (interferon beta-1b) for injection, for subcutaneous use Initial U.S. Approval: 1993
50419-524-812024-01-30These highlights do not include all the information needed to use BETASERON safely and effectively. See full prescribing information for BETASERON. BETASERON (interferon beta-1b) for injection, for subcutaneous use Initial U.S. Approval: 1993
50419-524-812024-01-30These highlights do not include all the information needed to use BETASERON safely and effectively. See full prescribing information for BETASERON. BETASERON (interferon beta-1b) for injection, for subcutaneous use Initial U.S. Approval: 1993
50419-524-812024-01-30These highlights do not include all the information needed to use BETASERON safely and effectively. See full prescribing information for BETASERON. BETASERON (interferon beta-1b) for injection, for subcutaneous use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50419-524-01Betaseron1 in 1 CARTONKIT129
50419-524-05Betaseron5 in 1 BOXKIT529
50419-524-09Betaseron1 in 1 BOXKIT129
50419-524-35Betaseron14 in 1 BOXKIT1429
50419-524-81Betaseron14 in 1 BOXKIT1429

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50419-524BETASERON (INTERFERON BETA-1B) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]23Current NDC, Legacy NDC, 5 package rows20240821_66311f74-0472-4fa3-848a-06002ca0def5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50419-524-01EA - Each50419-524c38dd881-23ee-4f5a-b0a7-f7ea716f041f12013-12-02
50419-524-35EA - Each50419-524bfbe2cc2-fb88-4a78-8415-f62752bf93e512013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INTERFERON BETA-1BACTIVE INGREDIENTTTD90R31WZBETASERON (INTERFERON BETA-1B) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]3
INTERFERON BETA-1BACTIVE MOIETYTTD90R31WZBETASERON (INTERFERON BETA-1B) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]3
ALBUMIN HUMANINACTIVE INGREDIENTZIF514RVZRBETASERON (INTERFERON BETA-1B) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]3
MANNITOLINACTIVE INGREDIENT3OWL53L36ABETASERON (INTERFERON BETA-1B) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XBETASERON (INTERFERON BETA-1B) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]3

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 6 of 44 · 870 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acne HPCARBO ANIMALIS, CARBO VEGETABILIS, KALI BICHROMICUM, NATRUM MURIATICUM, PULSATILLA (VULGARIS), SEPIA, SILICEA, SULPHUR, ZINCUM METALLICUMBioActive Nutritional, Inc.2ab4ff53-4274-40c7-b05c-44d918d809be2026-03-31WarningsExact identifier
unii: 451W47IQ8X
Cold Sore FormulaDULCAMARA, GLYCYRRHIZA GLABRA, RANUNCULUS BULBOSUS, RHUS TOX, NATRUM MURIATICUM, FAGOPYRUM ESCULENTUM, NATRUM HYPOCHLOROUS, ACONITUM NAPELLUS, CYTOMEGALOVIRUS NOSODE, HERPES SIMPLEX I AND II NOSODE, SEPIA, EPSTEIN BARR VIRUS NOSODE, HERPES ZOSTER NOSODE, ADENOVIREN NOSODENutritional Specialties, Inc.ad6a08ec-5eba-405b-8a07-79ac86ab3e7a2026-03-31WarningsExact identifier
unii: 451W47IQ8X
ANX HPARSENICUM ALBUM, CALCAREA CARBONICA, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, NATRUM MURIATICUMBioActive Nutritional, Inc.96035891-aea3-4138-bb26-801ad819f6392026-03-30WarningsExact identifier
unii: 451W47IQ8X
Spleen LiquescenceQUERCUS ROBUR, CEANOTHUS AMERICANUS, SPLEEN (BOVINE), NATRUM MURIATICUM, HELIANTHUS ANNUUSNutritional Specialties, Inc.d800456d-60f0-413d-b310-91b8b881f6b92026-03-30WarningsExact identifier
unii: 451W47IQ8X
DepressoforcePICRICUM ACIDUM, ARSENICUM ALBUM, AURUM METALLICUM, IGNATIA AMARA, NATRUM MURIATICUM, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SEPIABioActive Nutritional, Inc.e6b98979-a38c-4f13-af03-f5ffa962b4fa2026-03-27WarningsExact identifier
unii: 451W47IQ8X
AdrenaparARALIA QUINQUEFOLIA, AVENA SATIVA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS SUIS, ARSENICUM IODATUM, CALCAREA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ZINCUM METALLICUMEnergique, Inc.077a9171-283d-47b6-bddc-34c739f6d69d2026-03-27WarningsExact identifier
unii: 451W47IQ8X
Buffer pHCHAMOMILLA, GRAPHITES, KALI CARBONICUM, KALI OXALICUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, NUX VOMICA, RHEUM (PALMATUM), ROBINIA PSEUDOACACIANaturalCare2161a2e2-613d-4dac-a5f6-796d40e849d92026-03-25WarningsExact identifier
unii: 451W47IQ8X
Reflux AwayABIES NIGRA, ANTIMONIUM CRUDUM, ARGENTUM NITRICUM, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLOCYNTHIS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICANaturalCare8a00a72f-60df-4477-b7b8-abb6355e34da2026-03-24WarningsExact identifier
unii: 451W47IQ8X
Worafy Gentle Eye WashSODIUM CHLORIDEShenzhen Shandian Jingling Technology Co., Ltd.4da864dc-e10c-1db9-e063-6394a90a09842026-03-22WarningsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDE HYPERTONICITYSODIUM CHLORIDEYYBA CORP439653b9-99b8-4799-8d67-4a2ada9c67832026-03-20WarningsExact identifier
unii: 451W47IQ8X
Altachlore Sodium Chloride Hypertonicity Ophthalmic 5 PercentSODIUM CHLORIDEAltaire Pharmaceuticals Inc.e13fd053-9420-490c-a43e-e14b0930cb4e2026-03-18WarningsExact identifier
unii: 451W47IQ8X
UniversaltoxALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, HORDEUM VULGARE, NASTURTIUM AQUATICUM, RAPHANUS SATIVUS, TRITICUM AESTIVUM, IODIUM, UBIDECARENONUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, MANGANESE GLUCONATE, ORYZA SATIVA, THYROIDINUM (SUIS), CALCAREA CARBONICA, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), RHUS TOX, CORTISONE ACETICUMBioActive Nutritional, Inc.ad454e8a-4f78-4aac-90d9-a3f26a6fbe422026-03-17WarningsExact identifier
unii: 451W47IQ8X
BM BIO27CALC PHOS, KALI PHOS, NAT MURBM Private Limited4d229815-05f4-27c5-e063-6394a90ac8652026-03-16WarningsExact identifier
unii: 451W47IQ8X
BM BIO1CALC PHOS, FERR PHOS, KALI PHOS, NAT MURBM Private Limited4d265d99-fdbb-5efb-e063-6394a90a89ac2026-03-16WarningsExact identifier
unii: 451W47IQ8X
BM BIO16CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR.BM Private Limited4d26b4a9-ee27-6915-e063-6294a90a5d4d2026-03-16WarningsExact identifier
unii: 451W47IQ8X
BM BIO12FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR.BM Private Limited4d2747ad-958e-63a1-e063-6294a90aea662026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDEVenture Healthcare Ltd31b812c9-fb0a-5ee0-e063-6294a90a03e12026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDEVenture Healthcare Ltd31b88e7c-eca0-5540-e063-6294a90a1b182026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDEVenture Healthcare Ltd31b8c3f4-e528-c69d-e063-6294a90a5a342026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDELaboratoire Unither31b7eb13-39c3-6f0e-e063-6394a90a40112026-03-16WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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