betaseron

Generic: interferon beta-1b

Labeler: bayer healthcare pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name betaseron
Generic Name interferon beta-1b
Labeler bayer healthcare pharmaceuticals inc.
Dosage Form KIT
Manufacturer
Bayer HealthCare Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 50419-524
Product ID 50419-524_4ebf941b-8ad4-4faa-83d6-550b526270e9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA103471
Listing Expiration 2027-12-31
Marketing Start 2009-07-09

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50419524
Hyphenated Format 50419-524

Supplemental Identifiers

RxCUI
198360 207059

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name betaseron (source: ndc)
Generic Name interferon beta-1b (source: ndc)
Application Number BLA103471 (source: ndc)

Resolved Composition

Strengths
  • 0.3 mg
  • 3 ml
  • 1.2 ml
  • 0.54 %
source: label
Packaging
  • 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
  • 1 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 SYRINGE
  • 14 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 SYRINGE
  • 14 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 SYRINGE
source: ndc

Packages (4)

50419-524-05 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 50419-524-09 1 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 SYRINGE 50419-524-35 14 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 SYRINGE 50419-524-81 14 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 SYRINGE

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Betaseron ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "4ebf941b-8ad4-4faa-83d6-550b526270e9", "openfda": {"rxcui": ["198360", "207059"], "spl_set_id": ["66311f74-0472-4fa3-848a-06002ca0def5"], "manufacturer_name": ["Bayer HealthCare Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "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", "package_ndc": "50419-524-05", "marketing_start_date": "20090811"}, {"sample": false, "description": "1 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 SYRINGE", "package_ndc": "50419-524-09", "marketing_start_date": "20090811"}, {"sample": false, "description": "14 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 SYRINGE", "package_ndc": "50419-524-35", "marketing_start_date": "20090811"}, {"sample": false, "description": "14 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 SYRINGE", "package_ndc": "50419-524-81", "marketing_start_date": "20160901"}], "brand_name": "Betaseron", "product_id": "50419-524_4ebf941b-8ad4-4faa-83d6-550b526270e9", "dosage_form": "KIT", "product_ndc": "50419-524", "generic_name": "interferon beta-1b", "labeler_name": "Bayer HealthCare Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Betaseron", "application_number": "BLA103471", "marketing_category": "BLA", "marketing_start_date": "20090709", "listing_expiration_date": "20271231"}