capecitabine
- Product NDC
- 55111-497
- 11-digit product format
- 551110497
- Labeler code
- 55111
- Product ID
- 55111-497_25eb47d5-42ca-889b-6798-6f91d7795417
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- capecitabine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Limited
- Application
- ANDA204345
- Marketing category
- ANDA
- Marketing start
- 2020-12-10
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- capecitabine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CAPECITABINE | 500 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 |
|---|
| 55111-497-04 | capecitabine | 120 in 1 BOTTLE | TABLET | 120 | | 15 |
| 55111-497-05 | capecitabine | 500 in 1 BOTTLE | TABLET | 500 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55111-497 | CAPECITABINE TABLET [DR. REDDY'S LABORATORIES LIMITED] | 13 | Current NDC, Legacy NDC, 2 package rows | 20230719_007e3432-c8aa-2a76-52ba-c346924c08a7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55111-497-04 | 55111049704 | 120 TABLET in 1 BOTTLE (55111-497-04) | 120 tablet | 2020-12-10 | 0000-00-00 | No | No | Current |
| 55111-497-05 | 55111049705 | 500 TABLET in 1 BOTTLE (55111-497-05) | 500 tablet | 2020-12-10 | 0000-00-00 | No | No | Current |