NDC 68462-197 – Pravastatin Sodium
Pravastatin Sodium 40 mg/1 · Tablet · Oral
Product NDC68462-197
Product details
- Brand name
- Pravastatin Sodium
- Generic name
- Pravastatin Sodium
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Dosage form
- Tablet
- Route
- Oral
- Marketing category
- ANDA · ANDA077987
- Marketed since
- May 11, 2007
- Listing expires
- December 31, 2026
- Pharmacologic class
- HMG-CoA Reductase Inhibitor
Active ingredients
- Pravastatin Sodium 40 mg/1
Uses, dosage, side effects and warnings for Pravastatin Sodium →
Package NDC codes (2)
| Package NDC | Description | Since |
|---|---|---|
| 68462-197-05 | 500 TABLET in 1 BOTTLE (68462-197-05) | May 11, 2007 |
| 68462-197-90 | 90 TABLET in 1 BOTTLE (68462-197-90) | May 11, 2007 |
Recalls mentioning this NDC
- D-0341-2025 Apr 16, 2025 · Class II
CGMP Deviations - D-0325-2025 Apr 16, 2025 · Class II
CGMP Deviations - D-0612-2024 Jul 24, 2024 · Class II
Failed Dissolution Specifications: results below specifications - D-1120-2019 Apr 17, 2019 · Class II
Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg. - D-330-2013 May 22, 2013 · Class III
Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an off-odor described as moldy, musty or fishy in nature.
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