Prescription drug · BLA
Betaseron (Interferon beta-1b) NDC 50419-524
Kit · Bayer HealthCare Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 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 SYRINGEMarketed from Aug 11, 2009 | |
| 50419-524-09 | 50419052409 | 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 SYRINGEMarketed from Aug 11, 2009 | |
| 50419-524-35 | 50419052435 | 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 SYRINGEMarketed from Aug 11, 2009 | |
| 50419-524-81 | 50419052481 | 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 SYRINGEMarketed from Sep 1, 2016 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Betaseron
- Generic name (nonproprietary)
- interferon beta-1b
- Dosage form
- Kit
- Labeler
- Bayer HealthCare Pharmaceuticals Inc.NDC labeler code 50419
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 103471
- Marketing start
- Listing expires
- Identifiers
- Product ID 50419-524_4ebf941b-8ad4-4faa-83d6-550b526270e9SPL ID 4ebf941b-8ad4-4faa-83d6-550b526270e9SPL set ID 66311f74-0472-4fa3-848a-06002ca0def5RxCUI 198360, 207059
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N450419052405followed by a unit qualifier and the quantityPackage 50419-0524-05. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
BETASERON is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. BETASERON is an interferon beta indicated for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 50419-524
- What is NDC 50419-524?
- 50419-524 is the product NDC for Betaseron (interferon beta-1b) kit, listed with the FDA by Bayer HealthCare Pharmaceuticals Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Betaseron (Interferon beta-1b).
- Who is the labeler?
- Bayer HealthCare Pharmaceuticals Inc., NDC labeler code 50419. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Betaseron?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.