Home NDC 50419-524-05 Betaseron
Product NDC 50419-524
Requested package NDC 50419-524-05
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 Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Betaseron
Listing expiration 2027-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198360 Internal RxNorm lookup 207059 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 50419-524-05 2024-08-20 These 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 50419-524-05 2024-08-20 These 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 50419-524-05 2024-08-20 These 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 50419-524-09 2024-08-20 These 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 50419-524-09 2024-08-20 These 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 50419-524-09 2024-08-20 These 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 50419-524-35 2024-08-20 These 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 50419-524-35 2024-08-20 These 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 50419-524-35 2024-08-20 These 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 50419-524-81 2024-08-20 These 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 50419-524-81 2024-08-20 These 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 50419-524-81 2024-08-20 These 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 50419-524-05 2024-07-30 These 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 50419-524-05 2024-07-30 These 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 50419-524-05 2024-07-30 These 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 50419-524-09 2024-07-30 These 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 50419-524-09 2024-07-30 These 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 50419-524-09 2024-07-30 These 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 50419-524-35 2024-07-30 These 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 50419-524-35 2024-07-30 These 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 50419-524-35 2024-07-30 These 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 50419-524-81 2024-07-30 These 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 50419-524-81 2024-07-30 These 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 50419-524-81 2024-07-30 These 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 50419-524-05 2024-01-30 These 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 50419-524-05 2024-01-30 These 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 50419-524-05 2024-01-30 These 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 50419-524-09 2024-01-30 These 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 50419-524-09 2024-01-30 These 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 50419-524-09 2024-01-30 These 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 50419-524-35 2024-01-30 These 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 50419-524-35 2024-01-30 These 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 50419-524-35 2024-01-30 These 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 50419-524-81 2024-01-30 These 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 50419-524-81 2024-01-30 These 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 50419-524-81 2024-01-30 These 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# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50419-524 BETASERON (INTERFERON BETA-1B) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] 23 Current NDC, Legacy NDC, 5 package rows 20240821_66311f74-0472-4fa3-848a-06002ca0def5.zip
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 1 of 1 · 1 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 103471 Betaseron interferon beta-1b 351(a) Rx 2026-09-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50419-524-05 50419052405 5 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 SYRINGE 5 carton 2009-08-11 0000-00-00 No No Current