Prescription drug · ANDA
capecitabine NDC 31722-775
Capecitabine 500 mg/1 · Tablet, Film coated · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-775-12 | 31722077512 | 120 TABLET, FILM COATED in 1 BOTTLE (31722-775-12)Marketed from Mar 5, 2024 | |
| 31722-775-60 | 31722077560 | 60 TABLET, FILM COATED in 1 BOTTLE (31722-775-60)Marketed from Apr 19, 2024 |
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, Film coated
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210203
- Marketing start
- Listing expires
- Other FDA classes
- Nucleic Acid Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 31722-775_519e85b4-ff10-917f-e063-6394a90a12dfSPL ID 519e85b4-ff10-917f-e063-6394a90a12dfSPL set ID 3e7d6317-1439-4976-ae00-6f62619ec3ddRxCUI 200327, 200328UNII 6804DJ8Z9UUPC 0331722775601, 0331722774604
- 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
N431722077512followed by a unit qualifier and the quantityPackage 31722-0775-12. 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)
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.
Other NDCs under ANDA 210203
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| capecitabine | Capecitabine 150 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-774 |
| capecitabine | Capecitabine 500 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-303 |
| Capecitabine | Capecitabine 500 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-644 |
| Capecitabine | Capecitabine 150 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-643 |