NDC 65862-050 – Simvastatin
Simvastatin 5 mg/1 · Tablet, Film Coated · Oral
Product NDC65862-050
Product details
- Brand name
- Simvastatin
- Generic name
- Simvastatin
- Labeler
- Aurobindo Pharma Limited
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Marketing category
- ANDA · ANDA077691
- Marketed since
- December 20, 2006
- Listing expires
- December 31, 2027
- Pharmacologic class
- HMG-CoA Reductase Inhibitor
Active ingredients
- Simvastatin 5 mg/1
Package NDC codes (7)
| Package NDC | Description | Since |
|---|---|---|
| 65862-050-00 | 100 TABLET, FILM COATED in 1 BOTTLE (65862-050-00) | Dec 20, 2006 |
| 65862-050-01 | 100 TABLET, FILM COATED in 1 BOTTLE (65862-050-01) | Dec 20, 2006 |
| 65862-050-26 | 2500 TABLET, FILM COATED in 1 BOTTLE (65862-050-26) | Dec 20, 2006 |
| 65862-050-30 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-050-30) | Dec 20, 2006 |
| 65862-050-45 | 45 TABLET, FILM COATED in 1 BOTTLE (65862-050-45) | Dec 20, 2006 |
| 65862-050-90 | 90 TABLET, FILM COATED in 1 BOTTLE (65862-050-90) | Dec 20, 2006 |
| 65862-050-99 | 1000 TABLET, FILM COATED in 1 BOTTLE (65862-050-99) | Dec 20, 2006 |
Recalls mentioning this NDC
- D-1234-2020 Apr 22, 2020 · Class II
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed - D-1842-2019 Sep 4, 2019 · Class III
Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
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