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NDC 16571-0818-41 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 Rising Pharma Holdings, Inc.. The primary component is TEMOZOLOMIDE.
Product Information
| NDC | 16571-0818 |
|---|---|
| Product ID | 16571-818_f7c1aa83-a94a-4f97-bc30-66b8a89783b9 |
| Associated GPIs | |
| 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 | Rising Pharma Holdings, Inc. |
| Pharmaceutical Class | Alkylating Activity [MoA], Alkylating Drug [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA206309 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 16571-0818-41 (16571081841)
| NDC Package Code | 16571-818-41 |
|---|---|
| Billing NDC | 16571081841 |
| Package | 14 CAPSULE in 1 BOTTLE (16571-818-41) |
| Marketing Start Date | 2022-10-04 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |