capecitabine
- Product NDC
- 31722-774
- 11-digit product format
- 317220774
- Labeler code
- 31722
- Product ID
- 31722-774_519e85b4-ff10-917f-e063-6394a90a12df
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- capecitabine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA210203
- Marketing category
- ANDA
- Marketing start
- 2024-03-05
- 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 |
|---|
| 31722-774-60 | capecitabine | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-774 | CAPECITABINE (CAPECITABINE) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 2 | Current NDC, 1 package rows | 20240423_3e7d6317-1439-4976-ae00-6f62619ec3dd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 31722-774-60 | 31722077460 | 60 TABLET, FILM COATED in 1 BOTTLE (31722-774-60) | 2024-03-05 | No | No | Current |