Temozolomide
- Product NDC
- 47335-891
- 11-digit product format
- 473350891
- Labeler code
- 47335
- Product ID
- 47335-891_7c774570-443b-40da-8038-7cb550f92048
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Temozolomide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA201742
- Marketing category
- ANDA
- Marketing start
- 2014-02-13
- Substance
- TEMOZOLOMIDE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Alkylating Activity [MoA], Alkylating Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Temozolomide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TEMOZOLOMIDE | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | YF1K15M17Y |
| Rxcui | 313209, 313210, 313211, 317160, 700883, 700885 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47335-891 | TEMOZOLOMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 23 | Current NDC, Legacy NDC, 12 package rows | 20231013_c1e05c21-a411-4493-80de-ede373632475.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 47335-891-21 | 47335089121 | 1 BOTTLE in 1 CARTON (47335-891-21) / 14 CAPSULE in 1 BOTTLE | 1 bottle | 2014-02-13 | 0000-00-00 | No | No | Current |
| 47335-891-72 | 47335089172 | 15 BLISTER PACK in 1 CARTON (47335-891-72) / 1 CAPSULE in 1 BLISTER PACK | 15 blister pack | 2014-02-13 | 0000-00-00 | No | No | Current |
| 47335-891-74 | 47335089174 | 5 BLISTER PACK in 1 CARTON (47335-891-74) / 1 CAPSULE in 1 BLISTER PACK | 5 blister pack | 2014-02-13 | 0000-00-00 | No | No | Current |
| 47335-891-75 | 47335089175 | 20 BLISTER PACK in 1 CARTON (47335-891-75) / 1 CAPSULE in 1 BLISTER PACK | 20 blister pack | 2014-02-13 | 0000-00-00 | No | No | Current |
| 47335-891-80 | 47335089180 | 1 BOTTLE in 1 CARTON (47335-891-80) / 5 CAPSULE in 1 BOTTLE | 1 bottle | 2014-02-13 | 0000-00-00 | No | No | Current |
| 47335-891-87 | 47335089187 | 1 BOTTLE in 1 CARTON (47335-891-87) / 20 CAPSULE in 1 BOTTLE | 1 bottle | 2014-02-13 | 0000-00-00 | No | No | Current |