Temozolomide is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Roxane Laboratories, Inc.. The primary component is Temozolomide.
| Product ID | 0054-0320_910d587e-5e7b-4a49-ae91-e802baf4bff0 |
| NDC | 0054-0320 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Temozolomide |
| Generic Name | Temozolomide |
| Dosage Form | Capsule |
| Route of Administration | ORAL |
| Marketing Start Date | 2016-03-24 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA202606 |
| Labeler Name | Roxane Laboratories, Inc. |
| Substance Name | TEMOZOLOMIDE |
| Active Ingredient Strength | 5 mg/1 |
| Pharm Classes | Alkylating Activity [MoA],Alkylating Drug [EPC] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2018-12-31 |
| Marketing Category | ANDA |
| Application Number | ANDA202606 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2016-03-24 |
| Marketing End Date | 2016-03-24 |
| Marketing Category | ANDA |
| Application Number | ANDA202606 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2016-03-24 |
| Marketing End Date | 2016-03-24 |
| Ingredient | Strength |
|---|---|
| TEMOZOLOMIDE | 5 mg/1 |
| SPL SET ID: | 8f140343-1ddb-4346-a051-ad43f475c92b |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0054-0320 | Temozolomide | Temozolomide |
| 0054-0321 | Temozolomide | Temozolomide |
| 0054-0322 | Temozolomide | Temozolomide |
| 0054-0323 | Temozolomide | Temozolomide |
| 0054-0324 | Temozolomide | Temozolomide |
| 0054-0325 | Temozolomide | Temozolomide |
| 0093-7599 | Temozolomide | Temozolomide |
| 0093-7600 | Temozolomide | Temozolomide |
| 67877-537 | Temozolomide | Temozolomide |
| 67877-539 | Temozolomide | Temozolomide |
| 67877-540 | Temozolomide | Temozolomide |
| 67877-541 | Temozolomide | Temozolomide |
| 67877-542 | Temozolomide | Temozolomide |
| 67877-538 | Temozolomide | Temozolomide |
| 68382-751 | temozolomide | temozolomide |
| 68382-753 | temozolomide | temozolomide |
| 68382-756 | temozolomide | temozolomide |
| 68382-754 | temozolomide | temozolomide |
| 68382-755 | temozolomide | temozolomide |
| 68382-752 | temozolomide | temozolomide |
| 70771-1096 | temozolomide | temozolomide |
| 70771-1092 | temozolomide | temozolomide |
| 70771-1094 | temozolomide | temozolomide |
| 70771-1095 | temozolomide | temozolomide |
| 70771-1097 | temozolomide | temozolomide |
| 70771-1093 | temozolomide | temozolomide |
| 0781-2694 | Temozolomide | Temozolomide |
| 0781-2691 | Temozolomide | Temozolomide |
| 0781-2692 | Temozolomide | Temozolomide |
| 0781-2696 | Temozolomide | Temozolomide |
| 0781-2695 | Temozolomide | Temozolomide |
| 0781-2693 | Temozolomide | Temozolomide |
| 0093-7602 | Temozolomide | Temozolomide |
| 0093-7639 | Temozolomide | Temozolomide |
| 16729-130 | Temozolomide | Temozolomide |
| 16729-049 | Temozolomide | Temozolomide |
| 16729-050 | Temozolomide | Temozolomide |
| 0093-7601 | Temozolomide | Temozolomide |
| 0093-7638 | Temozolomide | Temozolomide |
| 16729-129 | Temozolomide | Temozolomide |
| 16729-051 | Temozolomide | Temozolomide |
| 16729-048 | Temozolomide | Temozolomide |
| 42737-101 | TEMOZOLOMIDE | TEMOZOLOMIDE |
| 42737-103 | TEMOZOLOMIDE | TEMOZOLOMIDE |
| 42737-106 | TEMOZOLOMIDE | TEMOZOLOMIDE |
| 42737-104 | TEMOZOLOMIDE | TEMOZOLOMIDE |
| 42737-102 | TEMOZOLOMIDE | TEMOZOLOMIDE |
| 42737-105 | TEMOZOLOMIDE | TEMOZOLOMIDE |
| 43975-252 | TEMOZOLOMIDE | TEMOZOLOMIDE |
| 43975-256 | TEMOZOLOMIDE | TEMOZOLOMIDE |