XELODA
- Product NDC
- 61269-475
- 11-digit product format
- 612690475
- Labeler code
- 61269
- Product ID
- 61269-475_32dd0155-c5cb-49c2-9b74-74f40df22df7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- capecitabine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- H2-Pharma, LLC
- Application
- NDA020896
- Marketing category
- NDA
- Marketing start
- 1998-04-30
- 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
- XELODA
- 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, 213292, 213293 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61269-475-12 | XELODA | 120 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 120 | | 32 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61269-475 | XELODA (CAPECITABINE) TABLET, FILM COATED [H2-PHARMA, LLC] | 30 | Current NDC, 1 package rows | 20250112_e702d84d-7162-4751-bf37-d724cc7e45a5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 61269-475-12 | 61269047512 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61269-475-12) | 1998-04-30 | No | No | Current |