SIMVASTATIN
- Product NDC
- 57297-480
- 11-digit product format
- 572970480
- Labeler code
- 57297
- Product ID
- 57297-480_c4be39fe-ec4b-4d8c-b540-9311111dac1c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SIMVASTATIN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- LUPIN LIMITED
- Application
- ANDA078103
- Marketing category
- ANDA
- Marketing start
- 2015-11-23
- Marketing end
- 0000-00-00
- Substance
- SIMVASTATIN
- Active strength
- 40 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 57297-480-01 | 2024-12-20 | C162847 | 48780-1 | 9d75b9d0-8a70-f424-e053-dadaa90a57ce | 688791fc-2841-4feb-a0ee-97d88ed9d8dc |
| 57297-480-02 | 2024-12-20 | C162847 | 48780-1 | 9d75b9d0-8a70-f424-e053-dadaa90a57ce | 688791fc-2841-4feb-a0ee-97d88ed9d8dc |
| 57297-480-03 | 2024-12-20 | C162847 | 48780-1 | 9d75b9d0-8a70-f424-e053-dadaa90a57ce | 688791fc-2841-4feb-a0ee-97d88ed9d8dc |
| 57297-480-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-8a70-f424-e053-dadaa90a57ce | 688791fc-2841-4feb-a0ee-97d88ed9d8dc |
| 57297-480-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-8a70-f424-e053-dadaa90a57ce | 688791fc-2841-4feb-a0ee-97d88ed9d8dc |
| 57297-480-03 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-8a70-f424-e053-dadaa90a57ce | 688791fc-2841-4feb-a0ee-97d88ed9d8dc |