NDC 70710-1592 – Icosapent ethyl
Icosapent Ethyl 1 g/1 · Capsule · Oral
Product NDC70710-1592
Product details
- Brand name
- Icosapent ethyl
- Generic name
- Icosapent ethyl
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Dosage form
- Capsule
- Route
- Oral
- Marketing category
- ANDA · ANDA217656
- Marketed since
- August 4, 2023
- Listing expires
- December 31, 2027
Active ingredients
- Icosapent Ethyl 1 g/1
Uses, dosage, side effects and warnings for Icosapent Ethyl →
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 70710-1592-7 | 120 CAPSULE in 1 BOTTLE (70710-1592-7) | Aug 4, 2023 |
Recalls mentioning this NDC
- D-0400-2026 Mar 18, 2026 · Class II
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient. - D-0295-2026 Jan 28, 2026 · Class II
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules - D-0497-2025 Jun 18, 2025 · Class II
Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.
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