What is NDC 50419-171?

50419-171 is the product NDC for Stivarga (regorafenib), Regorafenib 40 mg/1 tablet, film coated, listed with the FDA by Bayer HealthCare Pharmaceuticals Inc.. It has 4 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 Stivarga?

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.

Stivarga NDC 50419-171 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)50419-171Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50419-0171Add 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
50419-171-00	50419017100	210 BOTTLE in 1 BOX (50419-171-00) / 28 TABLET, FILM COATED in 1 BOTTLEMarketed from Sep 27, 2012
50419-171-03	50419017103	3 BOTTLE, PLASTIC in 1 BOX (50419-171-03) / 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-171-01)Marketed from Sep 27, 2012
50419-171-04	50419017104	1 BOTTLE, PLASTIC in 1 CARTON (50419-171-04) / 28 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Sep 27, 2012
50419-171-06	50419017106	4 BOTTLE, PLASTIC in 1 CARTON (50419-171-06) / 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-171-05)Marketed from May 1, 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): Stivarga
Generic name (nonproprietary): regorafenib
Active ingredients: Regorafenib — 40 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 203085
Marketing start: Sep 27, 2012
Listing expires: Dec 31, 2027
Other FDA classes: Breast Cancer Resistance Protein Inhibitors (Mechanism)Cytochrome P450 2C9 Inhibitors (Mechanism)Kinase Inhibitors (Mechanism)UGT1A1 Inhibitors (Mechanism)UGT1A9 Inhibitors (Mechanism)
Identifiers: Product ID 50419-171_8f47fb28-9855-4482-b807-e98c425c2a4eSPL ID 8f47fb28-9855-4482-b807-e98c425c2a4eSPL set ID 824f19c9-0546-4a8a-8d8f-c4055c04f7c7RxCUI 1312402, 1312408UNII MGN125FS9D
Pharmacologic class: Kinase Inhibitor

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

N450419017100 followed by a unit qualifier and the quantity

Package 50419-0171-00. 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 Feb 9, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

STIVARGA is a kinase inhibitor indicated for the treatment of adult patients with: • Metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy. ( 1.1 ) • Locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate. ( 1.2 ) • Hepatocellular carcinoma (HCC) who have been previously treated with sorafenib ( 1.3 ) 1.1 Colorectal Cancer STIVARGA is indicated for the treatment of adult patients with metastatic colorectal cancer (CRC) who have been previo…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50419-171

What is NDC 50419-171?: 50419-171 is the product NDC for Stivarga (regorafenib), Regorafenib 40 mg/1 tablet, film coated, 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?: Stivarga (Regorafenib).
What is the active ingredient?: Regorafenib.
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 Stivarga?: 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.

Stivarga (Regorafenib) NDC 50419-171