Capecitabine 500mg (capecitabine) NDC 72485-205

NDC codes

FDA NDC Directory

Product NDC (as listed)72485-205Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72485-0205Add 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
72485-205-12	72485020512	1 BOTTLE in 1 CARTON (72485-205-12) / 120 TABLET, FILM COATED in 1 BOTTLEMarketed from Mar 1, 2019

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): Capecitabine 500mg
Generic name (nonproprietary): capecitabine
Active ingredients: Capecitabine — 500 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Armas Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207456
Marketing start: Mar 1, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Nucleic Acid Synthesis Inhibitors (Mechanism)
Identifiers: Product ID 72485-205_dad6f70f-70c9-4152-bd36-9cb3537239daSPL ID dad6f70f-70c9-4152-bd36-9cb3537239daSPL set ID f050d16c-ab76-489d-b92c-8c155b4e3f7cRxCUI 200328UNII 6804DJ8Z9UUPC 0372485205127
Pharmacologic class: Nucleoside Metabolic 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

N472485020512 followed by a unit qualifier and the quantity

Package 72485-0205-12. 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 Dec 26, 2020. This label includes a boxed warning.

Indications (excerpt from the label)

Capecitabine tablets are a nucleoside metabolic inhibitor with antineoplastic activity indicated for: • Adjuvant Colon Cancer (1.1) – Patients with Dukes' C colon cancer • Metastatic Colorectal Cancer (1.1) – First-line as monotherapy when treatment with fluoropyrimidine therapy alone is preferred • Metastatic Breast Cancer (1.2) – In combination with docetaxel after failure of prior anthracycline containing therapy – As monotherapy in patients resistant to both paclitaxel and an anthracycline-containing regimen 1.1 Colorectal Cancer Capecitabine tablets are indicated as a single agent for adjuvant treatment in patients with Dukes' C colon cancer who have undergone complete resection of the …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207456

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 207456
Product	Strength	Form · route	Labeler	Product NDC
Capecitabine 150mgcapecitabine	Capecitabine 150 mg/1	Tablet, Film coatedOral	Armas Pharmaceuticals Inc.	72485-204