What is NDC 55111-497?

55111-497 is the product NDC for capecitabine, Capecitabine 500 mg/1 tablet, listed with the FDA by Dr. Reddy's Laboratories Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Dr. Reddy's Laboratories Limited, NDC labeler code 55111. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for capecitabine?

30 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

capecitabine NDC 55111-497 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)55111-497Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55111-0497Add 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
55111-497-04	5511104970455111049704	120 TABLET in 1 BOTTLE (55111-497-04)Marketed from Dec 10, 2020
55111-497-05	5511104970555111049705	500 TABLET in 1 BOTTLE (55111-497-05)Marketed from Dec 10, 2020

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 — 500 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Dr. Reddy's Laboratories LimitedNDC labeler code 55111
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204345
Marketing start: Dec 10, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Nucleic Acid Synthesis Inhibitors (Mechanism)
Identifiers: Product ID 55111-497_25eb47d5-42ca-889b-6798-6f91d7795417SPL ID 25eb47d5-42ca-889b-6798-6f91d7795417SPL set ID 007e3432-c8aa-2a76-52ba-c346924c08a7RxCUI 200327, 200328UNII 6804DJ8Z9UUPC 0355111496601, 0355111497042
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

N455111049704 followed by a unit qualifier and the quantity

Package 55111-0497-04. 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 Nov 20, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Capecitabine tablet 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 55111-497

What is NDC 55111-497?: 55111-497 is the product NDC for capecitabine, Capecitabine 500 mg/1 tablet, listed with the FDA by Dr. Reddy's Laboratories Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: capecitabine.
What is the active ingredient?: Capecitabine.
Who is the labeler?: Dr. Reddy's Laboratories Limited, NDC labeler code 55111. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for capecitabine?: 30 other product NDCs are listed under this name. See all capecitabine NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other capecitabine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Capecitabine	Capecitabine 150 mg/1	Tablet, Film coatedOral	CivicaScript LLC	82249-207	82249-0207-60
Capecitabine	Capecitabine 500 mg/1	Tablet, Film coatedOral	CivicaScript LLC	82249-210	82249-0210-12
Capecitabine	Capecitabine 500 mg/1	Tablet, Film coatedOral	BluePoint Laboratories	68001-644	68001-0644-07
Capecitabine	Capecitabine 150 mg/1	Tablet, Film coatedOral	BluePoint Laboratories	68001-643	68001-0643-06
capecitabine	Capecitabine 500 mg/1	Tablet, Film coatedOral	NorthStar RxLLC	72603-303	72603-0303-01
capecitabine	Capecitabine 150 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-774	31722-0774-60
capecitabine	Capecitabine 500 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-775	31722-0775-1231722-0775-60
Capecitabine	Capecitabine 500 mg/1	TabletOral	Quallent Pharmaceuticals Health LLC	82009-112	82009-0112-12
Capecitabine	Capecitabine 500 mg/1	Tablet, Film coatedOral	Cipla USA Inc.	69097-948	69097-0948-08
Capecitabine	Capecitabine 150 mg/1	Tablet, Film coatedOral	Cipla USA Inc.	69097-949	69097-0949-03

All 31 capecitabine NDCs

Other NDCs under ANDA 204345

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

FDA NDC Directory listings under ANDA 204345
Product	Strength	Form · route	Labeler	Product NDC
capecitabine	Capecitabine 150 mg/1	TabletOral	Dr. Reddy's Laboratories Limited	55111-496
Capecitabine	Capecitabine 500 mg/1	TabletOral	Quallent Pharmaceuticals Health LLC	82009-112