NDC 69097-030 – Nilotinib
Nilotinib 50 mg/1 · Capsule · Oral
Product NDC69097-030
Product details
- Brand name
- Nilotinib
- Generic name
- Nilotinib
- Labeler
- Cipla USA Inc.
- Dosage form
- Capsule
- Route
- Oral
- Marketing category
- NDA · NDA218922
- Marketed since
- June 18, 2025
- Listing expires
- December 31, 2026
- Pharmacologic class
- Kinase Inhibitor
Active ingredients
- Nilotinib 50 mg/1
Package NDC codes (2)
| Package NDC | Description | Since |
|---|---|---|
| 69097-030-08 | 120 CAPSULE in 1 BOTTLE, PLASTIC (69097-030-08) | Jun 18, 2025 |
| 69097-030-63 | 7 BLISTER PACK in 1 CARTON (69097-030-63) / 4 CAPSULE in 1 BLISTER PACK (69097-030-16) | Jun 18, 2025 |
Recalls mentioning this NDC
- D-0381-2026 Mar 11, 2026 · Class III
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test. - D-0382-2026 Mar 11, 2026 · Class III
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
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