Capecitabine
- Product NDC
- 68001-644
- 11-digit product format
- 680010644
- Labeler code
- 68001
- Product ID
- 68001-644_498ba415-dab9-ce68-e063-6394a90af1b4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Capecitabine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- BluePoint Laboratories
- Application
- ANDA210203
- Marketing category
- ANDA
- Marketing start
- 2025-04-22
- 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 |
|---|
| 68001-644-07 | Capecitabine | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68001-644 | CAPECITABINE TABLET, FILM COATED [BLUEPOINT LABORATORIES] | 2 | Current NDC, 1 package rows | 20250528_88c5af84-900a-4372-b056-bfea70c129cf.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68001-644-07 | 68001064407 | 120 TABLET, FILM COATED in 1 BOTTLE (68001-644-07) | 2025-04-22 | No | No | Current |