Prescription drug · ANDA
Capecitabine NDC 59651-204
Capecitabine 150 mg/1 · Tablet · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-204-10 | 5965102041059651020410 | 1 BLISTER PACK in 1 CARTON (59651-204-10) / 10 TABLET in 1 BLISTER PACKMarketed from Apr 17, 2018 | |
| 59651-204-60 | 5965102046059651020460 | 60 TABLET in 1 BOTTLE (59651-204-60)Marketed from Apr 17, 2018 |
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
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 59651
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210604
- Marketing start
- Listing expires
- Other FDA classes
- Nucleic Acid Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 59651-204_eee71cc5-a7d5-4e51-ab02-2fae12418585SPL ID eee71cc5-a7d5-4e51-ab02-2fae12418585SPL set ID 56441153-a1e5-4fdc-96d6-f21baa6b5fbeRxCUI 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
N459651020410followed by a unit qualifier and the quantityPackage 59651-0204-10. 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 tablets are 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.
About NDC 59651-204
- What is NDC 59651-204?
- 59651-204 is the product NDC for Capecitabine, Capecitabine 150 mg/1 tablet, listed with the FDA by Aurobindo Pharma 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?
- Aurobindo Pharma Limited, NDC labeler code 59651. 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.
Related NDCs: other Capecitabine products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 |
Other NDCs under ANDA 210604
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 500 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-205 |