temozolomide
- Product NDC
- 75834-145
- 11-digit product format
- 758340145
- Labeler code
- 75834
- Product ID
- 75834-145_9db23336-458a-46a6-a676-1702497a1891
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- temozolomide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Nivagen Pharmaceuticals, Inc.
- Application
- ANDA213328
- Marketing category
- ANDA
- Marketing start
- 2021-12-07
- Substance
- TEMOZOLOMIDE
- Active strength
- 180 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 | 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 |
|---|
| 75834-145-05 | temozolomide | 5 in 1 CARTON | CAPSULE | 5 | | 5 |
| 75834-145-05 | temozolomide | 1 in 1 CARTON | CAPSULE | 1 | | 5 |
| 75834-145-14 | temozolomide | 14 in 1 CARTON | CAPSULE | 14 | | 5 |
| 75834-145-14 | temozolomide | 1 in 1 CARTON | CAPSULE | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 75834-145 | TEMOZOLOMIDE CAPSULE [NIVAGEN PHARMACEUTICALS, INC.] | 5 | Current NDC, Legacy NDC, 4 package rows | 20211207_27e5a781-e4f2-4489-9def-7971d0b86d9c.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 |
|---|
| 75834-145-05 | 75834014505 | 1 CARTON in 1 CARTON (75834-145-05) / 5 CAPSULE in 1 CARTON | 1 carton | 2021-12-07 | 0000-00-00 | No | No | Current |
| 75834-145-14 | 75834014514 | 1 CARTON in 1 CARTON (75834-145-14) / 14 CAPSULE in 1 CARTON | 1 carton | 2021-12-07 | 0000-00-00 | No | No | Current |