TEMOZOLOMIDE
- Product NDC
- 16571-818
- 11-digit product format
- 165710818
- Labeler code
- 16571
- Product ID
- 16571-818_b75f958e-33bc-434d-a4ae-e5fa9d6f4ab5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- temozolomide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA206309
- Marketing category
- ANDA
- Marketing start
- 2022-10-04
- Substance
- TEMOZOLOMIDE
- Active strength
- 100 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 | 100 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 |
|---|
| 16571-818-02 | TEMOZOLOMIDE | 20 in 1 BOTTLE | CAPSULE | 20 | | 6 |
| 16571-818-41 | TEMOZOLOMIDE | 14 in 1 BOTTLE | CAPSULE | 14 | | 6 |
| 16571-818-51 | TEMOZOLOMIDE | 5 in 1 BOTTLE | CAPSULE | 5 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16571-818 | TEMOZOLOMIDE CAPSULE [RISING PHARMA HOLDINGS, INC.] | 6 | Current NDC, Legacy NDC, 3 package rows | 20240727_70996a9d-4a4f-4ed1-ab07-130486aa14ab.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 |
|---|
| 16571-818-02 | 16571081802 | 20 CAPSULE in 1 BOTTLE (16571-818-02) | 20 capsule | 2022-10-04 | 0000-00-00 | No | No | Current |
| 16571-818-41 | 16571081841 | 14 CAPSULE in 1 BOTTLE (16571-818-41) | 14 capsule | 2022-10-04 | 0000-00-00 | No | No | Current |
| 16571-818-51 | 16571081851 | 5 CAPSULE in 1 BOTTLE (16571-818-51) | 5 capsule | 2022-10-04 | 0000-00-00 | No | No | Current |