NDC 16571-818 – Temozolomide
Temozolomide 100 mg/1 · Capsule · Oral
Product NDC16571-818
Product details
- Brand name
- Temozolomide
- Generic name
- Temozolomide
- Labeler
- Rising Pharma Holdings, Inc.
- Dosage form
- Capsule
- Route
- Oral
- Marketing category
- ANDA · ANDA206309
- Marketed since
- October 4, 2022
- Listing expires
- December 31, 2026
- Pharmacologic class
- Alkylating Drug
Active ingredients
- Temozolomide 100 mg/1
Package NDC codes (3)
| Package NDC | Description | Since |
|---|---|---|
| 16571-818-02 | 20 CAPSULE in 1 BOTTLE (16571-818-02) | Oct 4, 2022 |
| 16571-818-41 | 14 CAPSULE in 1 BOTTLE (16571-818-41) | Oct 4, 2022 |
| 16571-818-51 | 5 CAPSULE in 1 BOTTLE (16571-818-51) | Oct 4, 2022 |
Recalls mentioning this NDC
- D-0384-2026 Mar 11, 2026 · Class II
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
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