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NDC 16729-0050-53 Temozolomide 100 mg/1 Details
Temozolomide 100 mg/1
Temozolomide is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Accord Healthcare Inc.. 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: 16729-0050-53Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Temozolomide
Product Information
| NDC | 16729-0050 |
|---|---|
| Product ID | 16729-050_0b85d412-d6c8-21cc-e063-6294a90a958c |
| Associated GPIs | 21104070000140 |
| GCN Sequence Number | 043012 |
| GCN Sequence Number Description | temozolomide CAPSULE 100 MG ORAL |
| HIC3 | V1A |
| HIC3 Description | ANTINEOPLASTIC - ALKYLATING AGENTS |
| GCN | 92913 |
| 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 | 100 |
| Active Ingredient Units | mg/1 |
| Substance Name | TEMOZOLOMIDE |
| Labeler Name | Accord Healthcare Inc. |
| Pharmaceutical Class | Alkylating Activity [MoA], Alkylating Drug [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA201528 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 16729-0050-53 (16729005053)
| NDC Package Code | 16729-050-53 |
|---|---|
| Billing NDC | 16729005053 |
| Package | 1 BOTTLE, GLASS in 1 CARTON (16729-050-53) / 5 CAPSULE in 1 BOTTLE, GLASS |
| Marketing Start Date | 2017-03-07 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |