NDC codes

FDA NDC Directory
Product NDC (as listed)50419-524Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50419-0524Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
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 SYRINGEMarketed from Aug 11, 2009
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 SYRINGEMarketed from Aug 11, 2009
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 SYRINGEMarketed from Aug 11, 2009
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 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

N450419052405 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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