CAPECITABINE
- Product NDC
- 68001-488
- 11-digit product format
- 680010488
- Labeler code
- 68001
- Product ID
- 68001-488_fcfd1ff2-e3d6-dfff-e053-6394a90ababe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CAPECITABINE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- BluePoint Laboratories
- Application
- ANDA202593
- Marketing category
- ANDA
- Marketing start
- 2021-02-22
- Substance
- CAPECITABINE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 6804DJ8Z9U | CAPECITABINE | 154361-50-9 | CAPECITABINE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68001-488-07 | 68001048807 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68001-488-07) | 2021-02-22 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| CAPECITABINE | BluePoint Laboratories | Intas Pharmaceuticals Ltd | 2023-05-31 | HUMAN PRESCRIPTION DRUG LABEL | 3 |