FDA.reportPublic FDA data

Betaseron

Product NDC
50419-524
11-digit product format
504190524
Labeler code
50419
Product ID
50419-524_4ebf941b-8ad4-4faa-83d6-550b526270e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
interferon beta-1b
Dosage form
KIT
Labeler
Bayer HealthCare Pharmaceuticals Inc.
Application
BLA103471
Marketing category
BLA
Marketing start
2009-07-09
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Betaseron
Listing expiration
2027-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui198360, 207059

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
06020223-841a-40e6-8d80-b038f9f0f5a6Product name120190411

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50419-524-052024-08-20C16284748780-11030e365-5f84-111a-e063-dadaa90a10e2These 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
50419-524-052024-08-20C16284748780-11030e365-5f84-111a-e063-dadaa90a10e2These 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
50419-524-052024-08-20C16284748780-11030e365-5f84-111a-e063-dadaa90a10e2These 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
50419-524-092024-08-20C16284748780-11030e365-5f84-111a-e063-dadaa90a10e2These 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
50419-524-092024-08-20C16284748780-11030e365-5f84-111a-e063-dadaa90a10e2These 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
50419-524-092024-08-20C16284748780-11030e365-5f84-111a-e063-dadaa90a10e2These 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
50419-524-352024-08-20C16284748780-11030e365-5f84-111a-e063-dadaa90a10e2These 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
50419-524-352024-08-20C16284748780-11030e365-5f84-111a-e063-dadaa90a10e2These 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
50419-524-352024-08-20C16284748780-11030e365-5f84-111a-e063-dadaa90a10e2These 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
50419-524-812024-08-20C16284748780-11030e365-5f84-111a-e063-dadaa90a10e2These 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
50419-524-812024-08-20C16284748780-11030e365-5f84-111a-e063-dadaa90a10e2These 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
50419-524-812024-08-20C16284748780-11030e365-5f84-111a-e063-dadaa90a10e2These 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
50419-524-052024-07-30C16284748780-11030e365-5f84-111a-e063-dadaa90a10e2These 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
50419-524-052024-07-30C16284748780-11030e365-5f84-111a-e063-dadaa90a10e2These 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
50419-524-052024-07-30C16284748780-11030e365-5f84-111a-e063-dadaa90a10e2These 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
50419-524-092024-07-30C16284748780-11030e365-5f84-111a-e063-dadaa90a10e2These 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
50419-524-092024-07-30C16284748780-11030e365-5f84-111a-e063-dadaa90a10e2These 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
50419-524-092024-07-30C16284748780-11030e365-5f84-111a-e063-dadaa90a10e2These 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
50419-524-352024-07-30C16284748780-11030e365-5f84-111a-e063-dadaa90a10e2These 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
50419-524-352024-07-30C16284748780-11030e365-5f84-111a-e063-dadaa90a10e2These 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
50419-524-352024-07-30C16284748780-11030e365-5f84-111a-e063-dadaa90a10e2These 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
50419-524-812024-07-30C16284748780-11030e365-5f84-111a-e063-dadaa90a10e2These 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
50419-524-812024-07-30C16284748780-11030e365-5f84-111a-e063-dadaa90a10e2These 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
50419-524-812024-07-30C16284748780-11030e365-5f84-111a-e063-dadaa90a10e2These 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
50419-524-052024-01-30C16284748780-11030e365-5f84-111a-e063-dadaa90a10e2These 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
50419-524-052024-01-30C16284748780-11030e365-5f84-111a-e063-dadaa90a10e2These 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
50419-524-052024-01-30C16284748780-11030e365-5f84-111a-e063-dadaa90a10e2These 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
50419-524-092024-01-30C16284748780-11030e365-5f84-111a-e063-dadaa90a10e2These 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
50419-524-092024-01-30C16284748780-11030e365-5f84-111a-e063-dadaa90a10e2These 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
50419-524-092024-01-30C16284748780-11030e365-5f84-111a-e063-dadaa90a10e2These 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
50419-524-352024-01-30C16284748780-11030e365-5f84-111a-e063-dadaa90a10e2These 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
50419-524-352024-01-30C16284748780-11030e365-5f84-111a-e063-dadaa90a10e2These 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
50419-524-352024-01-30C16284748780-11030e365-5f84-111a-e063-dadaa90a10e2These 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
50419-524-812024-01-30C16284748780-11030e365-5f84-111a-e063-dadaa90a10e2These 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
50419-524-812024-01-30C16284748780-11030e365-5f84-111a-e063-dadaa90a10e2These 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
50419-524-812024-01-30C16284748780-11030e365-5f84-111a-e063-dadaa90a10e2These 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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
207059BETASERON 0.3 MG InjectionPSN66311f74-0472-4fa3-848a-06002ca0def529
198360interferon beta-1b 0.3 MG InjectionPSN66311f74-0472-4fa3-848a-06002ca0def529
207059interferon beta-1b 0.3 MG Injection [Betaseron]SBD66311f74-0472-4fa3-848a-06002ca0def529
198360interferon beta-1b 0.3 MG InjectionSCD66311f74-0472-4fa3-848a-06002ca0def529
207059Betaseron 0.3 MG InjectionSY66311f74-0472-4fa3-848a-06002ca0def529

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50419-524-01504190524011 in 1 CARTONHistorical
50419-524-05504190524055 CARTON in 1 BOX (50419-524-05) / 1 KIT in 1 CARTON (50419-524-01) * 1 mL in 1 VIAL, SINGLE-USE * 1.2 mL in 1 SYRINGE5 carton2009-08-110000-00-00NoNoCurrent
50419-524-09504190524091 CARTON in 1 BOX (50419-524-09) / 1 KIT in 1 CARTON (50419-524-01) * 1 mL in 1 VIAL, SINGLE-USE * 1.2 mL in 1 SYRINGE1 carton2009-08-110000-00-00NoNoCurrent
50419-524-355041905243514 CARTON in 1 BOX (50419-524-35) / 1 KIT in 1 CARTON (50419-524-01) * 1 mL in 1 VIAL, SINGLE-USE * 1.2 mL in 1 SYRINGE14 carton2009-08-110000-00-00NoNoCurrent
50419-524-815041905248114 CARTON in 1 BOX (50419-524-81) / 1 KIT in 1 CARTON (50419-524-01) * 1 mL in 1 VIAL, SINGLE-USE * 1.2 mL in 1 SYRINGE14 carton2016-09-010000-00-00NoNoCurrent