NDC 65862-053 – Simvastatin
Simvastatin 40 mg/1 · Tablet, Film Coated · Oral
Product NDC65862-053
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 40 mg/1
Package NDC codes (7)
| Package NDC | Description | Since |
|---|---|---|
| 65862-053-00 | 100 TABLET, FILM COATED in 1 BOTTLE (65862-053-00) | Dec 20, 2006 |
| 65862-053-01 | 100 TABLET, FILM COATED in 1 BOTTLE (65862-053-01) | Dec 20, 2006 |
| 65862-053-22 | 2000 TABLET, FILM COATED in 1 BOTTLE (65862-053-22) | Dec 20, 2006 |
| 65862-053-30 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-053-30) | Dec 20, 2006 |
| 65862-053-45 | 45 TABLET, FILM COATED in 1 BOTTLE (65862-053-45) | Dec 20, 2006 |
| 65862-053-90 | 90 TABLET, FILM COATED in 1 BOTTLE (65862-053-90) | Dec 20, 2006 |
| 65862-053-99 | 1000 TABLET, FILM COATED in 1 BOTTLE (65862-053-99) | 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
Other Simvastatin products
- 50090-4736 Simvastatin 40 mg/1 · Tablet, Film Coated · A-S Medication Solutions
- 50090-4897 Simvastatin 20 mg/1 · Tablet, Film Coated · A-S Medication Solutions
- 50090-4801 Simvastatin 20 mg/1 · Tablet, Film Coated · A-S Medication Solutions
- 50090-6306 Simvastatin 20 mg/1 · Tablet, Film Coated · A-S Medication Solutions
- 50090-5788 Simvastatin 80 mg/1 · Tablet, Film Coated · A-S Medication Solutions
- 50090-6236 Simvastatin 10 mg/1 · Tablet, Film Coated · A-S Medication Solutions
- 50090-4901 Simvastatin 40 mg/1 · Tablet, Film Coated · A-S Medication Solutions
- 50090-5019 Simvastatin 20 mg/1 · Tablet, Film Coated · A-S Medication Solutions
- 50090-6307 Simvastatin 20 mg/1 · Tablet, Film Coated · A-S Medication Solutions
- 50090-6389 Simvastatin 20 mg/1 · Tablet, Film Coated · A-S Medication Solutions
- 50090-6390 Simvastatin 20 mg/1 · Tablet, Film Coated · A-S Medication Solutions
- 50090-6421 Simvastatin 40 mg/1 · Tablet, Film Coated · A-S Medication Solutions