Capecitabine
- Product NDC
- 0093-7474
- 11-digit product format
- 000937474
- Labeler code
- 0093
- Product ID
- 0093-7474_94cd2146-70ff-43e3-a896-b9e55d75540f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Capecitabine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA091649
- Marketing category
- ANDA
- Marketing start
- 2014-03-07
- 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 |
|---|
| 0093-7474-89 | Capecitabine | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 14 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CAPECITABINE | ACTIVE INGREDIENT | 6804DJ8Z9U | CAPECITABINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| CAPECITABINE | ACTIVE MOIETY | 6804DJ8Z9U | CAPECITABINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | CAPECITABINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CAPECITABINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | CAPECITABINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | CAPECITABINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | CAPECITABINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| HYPROMELLOSE 2910 (3 MPA.S) | INACTIVE INGREDIENT | 0VUT3PMY82 | CAPECITABINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | CAPECITABINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CAPECITABINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | CAPECITABINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CAPECITABINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| CAPECITABINE | ACTIVE INGREDIENT | 6804DJ8Z9U | CAPECITABINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| CAPECITABINE | ACTIVE MOIETY | 6804DJ8Z9U | CAPECITABINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | CAPECITABINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CAPECITABINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | CAPECITABINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | CAPECITABINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | CAPECITABINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| HYPROMELLOSE 2910 (3 MPA.S) | INACTIVE INGREDIENT | 0VUT3PMY82 | CAPECITABINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | CAPECITABINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CAPECITABINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | CAPECITABINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CAPECITABINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-7474 | CAPECITABINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] | 13 | Current NDC, Legacy NDC, 1 package rows | 20240815_5753679a-506c-4ac4-b8b2-b27c664d1d40.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 |
|---|
| 0093-7474-89 | 00093747489 | 120 TABLET, FILM COATED in 1 BOTTLE (0093-7474-89) | 2014-03-07 | 0000-00-00 | No | No | Current |