Temozolomide
- Product NDC
- 67877-542
- 11-digit product format
- 678770542
- Labeler code
- 67877
- Product ID
- 67877-542_f519f4f0-bb62-43cb-bfc2-15f00ac1aad3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Temozolomide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA207658
- Marketing category
- ANDA
- Marketing start
- 2017-04-28
- Substance
- TEMOZOLOMIDE
- Active strength
- 250 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 | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | YF1K15M17Y |
| Rxcui | 313209, 313210, 313211, 317160, 700883, 700885 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 67877-542-07 | 2023-03-21 | C162847 | 48780-1 | ba0f9c33-4a5b-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use TEMOZOLOMIDE CAPSULES, USP safely and effectively. See full prescribing information for TEMOZOLOMIDE CAPSULES, USP. TEMOZOLOMIDE Capsules for oral use Initial U.S. Approval: 1999 |
| 67877-542-07 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-4a5b-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use TEMOZOLOMIDE CAPSULES, USP safely and effectively. See full prescribing information for TEMOZOLOMIDE CAPSULES, USP. TEMOZOLOMIDE Capsules for oral use Initial U.S. Approval: 1999 |
| 67877-542-07 | 2021-07-09 | C162847 | 48780-1 | ba0f9c33-4a5b-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use TEMOZOLOMIDE CAPSULES, USP safely and effectively. See full prescribing information for TEMOZOLOMIDE CAPSULES, USP. TEMOZOLOMIDE Capsules for oral use Initial U.S. Approval: 1999 |
| 67877-542-07 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-4a5b-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use TEMOZOLOMIDE CAPSULES, USP safely and effectively. See full prescribing information for TEMOZOLOMIDE CAPSULES, USP. TEMOZOLOMIDE Capsules for oral use Initial U.S. Approval: 1999 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67877-542-07 | Temozolomide | 5 in 1 BOTTLE | CAPSULE | 5 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-542 | TEMOZOLOMIDE CAPSULE [ASCEND LABORATORIES, LLC] | 9 | Current NDC, Legacy NDC, 1 package rows | 20250112_33d67bce-38ae-45fc-a858-d51167b0ecfd.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 |
|---|
| 67877-542-07 | 67877054207 | 5 CAPSULE in 1 BOTTLE (67877-542-07) | 5 capsule | 2017-04-28 | 0000-00-00 | No | No | Current |