Simvastatin
- Product NDC
- 68645-470
- 11-digit product format
- 686450470
- Labeler code
- 68645
- Product ID
- 68645-470_e87e1409-83ce-6e67-e053-2995a90ae8b4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Simvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Legacy Pharmaceutical Packaging, LLC
- Application
- ANDA078103
- Marketing category
- ANDA
- Marketing start
- 2007-06-01
- Marketing end
- 0000-00-00
- Substance
- SIMVASTATIN
- Active strength
- 20 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68645-470 | SIMVASTATIN TABLET, FILM COATED SIMVASTATIN TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC] | 11 | Legacy NDC | 20241016_462cc021-2c48-4665-b9a9-f293d153fb03.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68645-470-54 | 68645047054 | 30 TABLET, FILM COATED in 1 BOTTLE (68645-470-54) | 2007-06-01 | 0000-00-00 | No | No | Current |