Temozolomide
- Product NDC
- 82249-412
- 11-digit product format
- 822490412
- Labeler code
- 82249
- Product ID
- 82249-412_52339839-480f-4e9a-813e-8c27917ee38a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Temozolomide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- CivicaScript LLC
- Application
- ANDA207658
- Marketing category
- ANDA
- Marketing start
- 2017-04-28
- Substance
- TEMOZOLOMIDE
- Active strength
- 180 mg/1
- Pharmacologic classes
- Alkylating Activity [MoA], Alkylating Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Temozolomide
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TEMOZOLOMIDE | 180 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | YF1K15M17Y |
| Rxcui | 313209, 313210, 313211, 317160, 700883, 700885 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82249-412-05 | Temozolomide | 5 in 1 BOTTLE | CAPSULE | 5 | | 2 |
| 82249-412-14 | Temozolomide | 14 in 1 BOTTLE | CAPSULE | 14 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82249-412-05 | 82249041205 | 5 CAPSULE in 1 BOTTLE (82249-412-05) | 5 capsule | 2025-04-01 | No | No | Current |
| 82249-412-14 | 82249041214 | 14 CAPSULE in 1 BOTTLE (82249-412-14) | 14 capsule | 2025-04-01 | No | No | Current |