Prescription drug · NDA
Xeloda (capecitabine) NDC 61269-475
Capecitabine 500 mg/1 · Tablet, Film coated · Oral · H2-Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61269-475-12 | 61269047512 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61269-475-12)Marketed from Apr 30, 1998 |
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)
- Xeloda
- Generic name (nonproprietary)
- capecitabine
- Active ingredients
- Capecitabine — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- H2-Pharma, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020896
- Marketing start
- Listing expires
- Other FDA classes
- Nucleic Acid Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 61269-475_32dd0155-c5cb-49c2-9b74-74f40df22df7SPL ID 32dd0155-c5cb-49c2-9b74-74f40df22df7SPL set ID e702d84d-7162-4751-bf37-d724cc7e45a5RxCUI 200327, 200328, 213292, 213293UNII 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
N461269047512followed by a unit qualifier and the quantityPackage 61269-0475-12. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
XELODA (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 patient…
Excerpt only. Read the full label for complete information.