Capecitabine
- Product NDC
- 67877-458
- 11-digit product format
- 678770458
- Labeler code
- 67877
- Product ID
- 67877-458_1979fce8-8d4b-416c-b437-bcd4fc1232ec
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Capecitabine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA207652
- Marketing category
- ANDA
- Marketing start
- 2017-11-25
- 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
- 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 | 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 |
|---|
| 67877-458-12 | Capecitabine | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 17 |
| 67877-458-30 | Capecitabine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 17 |
| 67877-458-60 | Capecitabine | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 17 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-458 | CAPECITABINE TABLET, FILM COATED [ASCEND LABORATORIES, LLC] | 14 | Current NDC, Legacy NDC, 3 package rows | 20241001_06a88b03-6c06-4dae-b3bc-1e8dd81c9067.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67877-458-12 | 67877045812 | 120 TABLET, FILM COATED in 1 BOTTLE (67877-458-12) | 2017-11-25 | 0000-00-00 | No | No | Current |
| 67877-458-30 | 67877045830 | 30 TABLET, FILM COATED in 1 BOTTLE (67877-458-30) | 2017-11-25 | 0000-00-00 | No | No | Current |
| 67877-458-60 | 67877045860 | 60 TABLET, FILM COATED in 1 BOTTLE (67877-458-60) | 2019-05-01 | 0000-00-00 | No | No | Current |