What is NDC 50419-395?

50419-395 is the product NDC for Nubeqa (darolutamide), Darolutamide 300 mg/1 tablet, film coated, listed with the FDA by Bayer HealthCare Pharmaceuticals Inc.. It has 2 package NDCs, 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 Nubeqa?

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.

Nubeqa NDC 50419-395 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)50419-395Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50419-0395Add 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
50419-395-01	50419039501	1 BOTTLE in 1 CARTON (50419-395-01) / 120 TABLET, FILM COATED in 1 BOTTLEMarketed from Jul 31, 2019
50419-395-72	50419039572	1 BOTTLE in 1 CARTON (50419-395-72) / 120 TABLET, FILM COATED in 1 BOTTLEMarketed from Mar 3, 2021

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): Nubeqa
Generic name (nonproprietary): darolutamide
Active ingredients: Darolutamide — 300 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 212099
Marketing start: Jul 31, 2019
Listing expires: Dec 31, 2027
Identifiers: Product ID 50419-395_fd96ab4c-d7f4-446f-93d8-1dae246a450aSPL ID fd96ab4c-d7f4-446f-93d8-1dae246a450aSPL set ID 1a7cb212-56e4-4b9d-a73d-bfee7fe4735eRxCUI 2180330, 2180336UNII X05U0N2RCO

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

N450419039501 followed by a unit qualifier and the quantity

Package 50419-0395-01. 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

Current FDA label (SPL), effective Jun 3, 2025.

Indications (excerpt from the label)

NUBEQA is an androgen receptor inhibitor indicated for the treatment of adult patients with: non-metastatic castration-resistant prostate cancer (nmCRPC). ( 1 ) metastatic castration-sensitive prostate cancer (mCSPC). ( 1 ) metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel. ( 1 ) NUBEQA is indicated for the treatment of adult patients with: non-metastatic castration resistant prostate cancer (nmCRPC) metastatic castration-sensitive prostate cancer (mCSPC) metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50419-395

What is NDC 50419-395?: 50419-395 is the product NDC for Nubeqa (darolutamide), Darolutamide 300 mg/1 tablet, film coated, listed with the FDA by Bayer HealthCare Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Nubeqa (Darolutamide).
What is the active ingredient?: Darolutamide.
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 Nubeqa?: 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.

Nubeqa (Darolutamide) NDC 50419-395