Capecitabine
- Product NDC
- 82511-001
- 11-digit product format
- 825110001
- Labeler code
- 82511
- Product ID
- 82511-001_2b3f98b5-d81c-d87d-e063-6294a90a7e87
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- capecitabine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Teyro Labs Private Limited
- Application
- ANDA217237
- Marketing category
- ANDA
- Marketing start
- 2022-02-16
- Substance
- CAPECITABINE
- Active strength
- 150 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Capecitabine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CAPECITABINE | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6804DJ8Z9U |
| Rxcui | 200327, 200328 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82511-001-15 | Capecitabine | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82511-001 | CAPECITABINE TABLET, FILM COATED [TEYRO LABS PRIVATE LIMITED] | 2 | Current NDC, 1 package rows | 20250110_0c873e5b-51c2-4685-86c5-53f98563b093.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82511-001-15 | 82511000115 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82511-001-15) | 2022-09-01 | No | No | Current |