Temozolomide
- Product NDC
- 65162-802
- 11-digit product format
- 651620802
- Labeler code
- 65162
- Product ID
- 65162-802_7cf62d84-45c0-405c-975b-3dbcbcf5ee27
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Temozolomide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA203691
- Marketing category
- ANDA
- Marketing start
- 2015-04-03
- 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#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65162-802-14 | Temozolomide | 1 in 1 CARTON | CAPSULE | 1 | | 26 |
| 65162-802-14 | Temozolomide | 14 in 1 BOTTLE | CAPSULE | 14 | | 26 |
| 65162-802-51 | Temozolomide | 5 in 1 BOTTLE | CAPSULE | 5 | | 26 |
| 65162-802-51 | Temozolomide | 1 in 1 CARTON | CAPSULE | 1 | | 26 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-802 | TEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS LLC] | 26 | Current NDC, Legacy NDC, 4 package rows | 20250124_6c8529ec-8936-4fec-a1a5-2b285c7e4859.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 |
|---|
| 65162-802-14 | 65162080214 | 1 BOTTLE in 1 CARTON (65162-802-14) / 14 CAPSULE in 1 BOTTLE | 1 bottle | 2015-04-03 | 0000-00-00 | No | No | Current |
| 65162-802-51 | 65162080251 | 1 BOTTLE in 1 CARTON (65162-802-51) / 5 CAPSULE in 1 BOTTLE | 1 bottle | 2015-04-03 | 0000-00-00 | No | No | Current |