NDC 67877-539 – Temozolomide
Temozolomide 100 mg/1 · Capsule · Oral
Product NDC67877-539
Product details
- Brand name
- Temozolomide
- Generic name
- Temozolomide
- Labeler
- Ascend Laboratories, LLC
- Dosage form
- Capsule
- Route
- Oral
- Marketing category
- ANDA · ANDA207658
- Marketed since
- April 28, 2017
- Listing expires
- December 31, 2026
- Pharmacologic class
- Alkylating Drug
Active ingredients
- Temozolomide 100 mg/1
Package NDC codes (2)
| Package NDC | Description | Since |
|---|---|---|
| 67877-539-07 | 5 CAPSULE in 1 BOTTLE (67877-539-07) | Apr 28, 2017 |
| 67877-539-14 | 14 CAPSULE in 1 BOTTLE (67877-539-14) | Apr 28, 2017 |
Recalls mentioning this NDC
- D-1509-2019 Jul 31, 2019 · Class II
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. - D-1512-2019 Jul 31, 2019 · Class II
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. - D-1510-2019 Jul 31, 2019 · Class II
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. - D-1511-2019 Jul 31, 2019 · Class II
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. - D-1513-2019 Jul 31, 2019 · Class II
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. - D-1508-2019 Jul 31, 2019 · Class II
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
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