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NDC 67877-0537-07 Temozolomide 5 mg/1 Details
Temozolomide 5 mg/1
Temozolomide is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Ascend Laboratories, LLC. The primary component is TEMOZOLOMIDE.
MedlinePlus Drug Summary
Temozolomide is used to treat certain types of brain tumors. Temozolomide is in a class of medications called alkylating agents. It works by slowing or stopping the growth of cancer cells in your body.
Related Packages: 67877-0537-07Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Temozolomide
Product Information
| NDC | 67877-0537 |
|---|---|
| Product ID | 67877-537_2d0558e6-e623-468d-8478-148f89e24c88 |
| Associated GPIs | 21104070000110 |
| GCN Sequence Number | 043010 |
| GCN Sequence Number Description | temozolomide CAPSULE 5 MG ORAL |
| HIC3 | V1A |
| HIC3 Description | ANTINEOPLASTIC - ALKYLATING AGENTS |
| GCN | 92893 |
| HICL Sequence Number | 020355 |
| HICL Sequence Number Description | TEMOZOLOMIDE |
| Brand/Generic | Generic |
| Proprietary Name | Temozolomide |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Temozolomide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/1 |
| Substance Name | TEMOZOLOMIDE |
| Labeler Name | Ascend Laboratories, LLC |
| Pharmaceutical Class | Alkylating Activity [MoA], Alkylating Drug [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA207658 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 67877-0537-07 (67877053707)
| NDC Package Code | 67877-537-07 |
|---|---|
| Billing NDC | 67877053707 |
| Package | 5 CAPSULE in 1 BOTTLE (67877-537-07) |
| Marketing Start Date | 2017-04-28 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |