Capecitabine NDC 16729-072

NDC codes

FDA NDC Directory

Product NDC (as listed)16729-072Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16729-0072Add 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
16729-072-12	16729007212	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-072-12)Marketed from Jun 9, 2015

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
Generic name (nonproprietary): capecitabine
Active ingredients: Capecitabine — 150 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Accord Healthcare Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202593
Marketing start: Jun 9, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Nucleic Acid Synthesis Inhibitors (Mechanism)
Identifiers: Product ID 16729-072_0e1e6b8e-1e8f-3b26-e063-6294a90ad5fbSPL ID 0e1e6b8e-1e8f-3b26-e063-6294a90ad5fbSPL set ID 8345d55e-ad02-4726-a04b-1a46e3337a4bRxCUI 200327, 200328UNII 6804DJ8Z9U
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

N416729007212 followed by a unit qualifier and the quantity

Package 16729-0072-12. 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 Jan 4, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Capecitabine is a nucleoside metabolic inhibitor indicated for: Colorectal Cancer adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen. ( 1.1 ) perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy. ( 1.1 ) treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen. ( 1.1 ) Breast Cancer treatment of patients with advanced or metastatic breast cancer as a single agent if an anthracycline- or taxane-containing chemotherapy is not indicated. ( 1.2 ) treatment of patients with ad…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202593

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

FDA NDC Directory listings under ANDA 202593
Product	Strength	Form · route	Labeler	Product NDC
Capecitabine	Capecitabine 150 mg/1	Tablet, Film coatedOral	BluePoint Laboratories	68001-487
Capecitabine	Capecitabine 500 mg/1	Tablet, Film coatedOral	BluePoint Laboratories	68001-488
Capecitabine	Capecitabine 500 mg/1	Tablet, Film coatedOral	Accord Healthcare Inc.	16729-073