Capecitabine
- Product NDC
- 69097-948
- 11-digit product format
- 690970948
- Labeler code
- 69097
- Product ID
- 69097-948_c1549b67-948e-402d-9ba4-6fc16237df8f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Capecitabine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Cipla USA Inc.
- Application
- ANDA209365
- Marketing category
- ANDA
- Marketing start
- 2023-07-01
- 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 | 200327, 200328 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69097-948-08 | Capecitabine | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69097-948 | CAPECITABINE TABLET, FILM COATED [CIPLA USA INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20230701_2871c37d-5e55-437b-a434-fc86d845492a.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 |
|---|
| 69097-948-08 | 69097094808 | 120 TABLET, FILM COATED in 1 BOTTLE (69097-948-08) | 2023-07-01 | 0000-00-00 | No | No | Current |