NDC 68462-322 – ezetimibe and simvastatin
Ezetimibe 10 mg/1; Simvastatin 20 mg/1 · Tablet · Oral
Product NDC68462-322
Product details
- Brand name
- ezetimibe and simvastatin
- Generic name
- ezetimibe and simvastatin
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Dosage form
- Tablet
- Route
- Oral
- Marketing category
- ANDA · ANDA208699
- Marketed since
- June 27, 2019
- Listing expires
- December 31, 2026
- Pharmacologic class
- Dietary Cholesterol Absorption Inhibitor; HMG-CoA Reductase Inhibitor
Active ingredients
- Ezetimibe 10 mg/1
- Simvastatin 20 mg/1
Uses, dosage, side effects and warnings for ezetimibe and simvastatin →
Package NDC codes (3)
| Package NDC | Description | Since |
|---|---|---|
| 68462-322-10 | 1000 TABLET in 1 BOTTLE (68462-322-10) | Jun 27, 2019 |
| 68462-322-30 | 30 TABLET in 1 BOTTLE (68462-322-30) | Jun 27, 2019 |
| 68462-322-90 | 90 TABLET in 1 BOTTLE (68462-322-90) | Jun 27, 2019 |
Recalls mentioning this NDC
- D-0462-2025 Jun 18, 2025 · Class III
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study. - D-0484-2021 Jun 2, 2021 · Class II
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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