Capecitabine
- Product NDC
- 82009-112
- 11-digit product format
- 820090112
- Labeler code
- 82009
- Product ID
- 82009-112_42afca74-0031-860a-7824-317742a8664d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Capecitabine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Quallent Pharmaceuticals Health LLC
- Application
- ANDA204345
- Marketing category
- ANDA
- Marketing start
- 2023-07-21
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Capecitabine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CAPECITABINE | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6804DJ8Z9U |
| Rxcui | 200328 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82009-112-12 | Capecitabine | 120 in 1 BOTTLE | TABLET | 120 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82009-112 | CAPECITABINE TABLET [QUALLENT PHARMACEUTICALS HEALTH LLC] | 1 | Current NDC, 1 package rows | 20230809_d23f023a-ea62-4ac0-f615-d5d26d59526d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82009-112-12 | 82009011212 | 120 TABLET in 1 BOTTLE (82009-112-12) | 120 tablet | 2023-07-21 | No | No | Current |