What is NDC 50419-397?

50419-397 is the product NDC for Hyrnuo (sevabertinib), Sevabertinib 10 mg/1 tablet, film coated, listed with the FDA by Bayer HealthCare Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

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 Hyrnuo?

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.

Hyrnuo NDC 50419-397 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)50419-397Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50419-0397Add 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 NDC	11-digit (billing)	Package	Copy
50419-397-01	50419039701	120 TABLET, FILM COATED in 1 BOTTLE (50419-397-01)Marketed from Nov 19, 2025

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): Hyrnuo
Generic name (nonproprietary): sevabertinib
Active ingredients: Sevabertinib — 10 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Bayer HealthCare Pharmaceuticals Inc.NDC labeler code 50419
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 219972
Marketing start: Nov 19, 2025
Listing expires: Dec 31, 2027
Identifiers: Product ID 50419-397_2ba86679-0db2-44b4-86d1-e69413e24762SPL ID 2ba86679-0db2-44b4-86d1-e69413e24762

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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N450419039701 followed by a unit qualifier and the quantity

Package 50419-0397-01. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 50419-397

What is NDC 50419-397?: 50419-397 is the product NDC for Hyrnuo (sevabertinib), Sevabertinib 10 mg/1 tablet, film coated, listed with the FDA by Bayer HealthCare Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Hyrnuo (Sevabertinib).
What is the active ingredient?: Sevabertinib.
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 Hyrnuo?: 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.

Hyrnuo (Sevabertinib) NDC 50419-397