Lovastatin
- Product NDC
- 68788-0926
- 11-digit product format
- 687880926
- Labeler code
- 68788
- Product ID
- 68788-0926_d17256be-9775-49d0-aecc-3ee197ecaa17
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lovastatin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA075828
- Marketing category
- ANDA
- Marketing start
- 2013-03-18
- Marketing end
- 0000-00-00
- Substance
- LOVASTATIN
- Active strength
- 10 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A075828-001 | LOVASTATIN | LOVASTATIN | 10MG | TABLET / ORAL | AB | | 2001-12-17 |
| A075828-002 | LOVASTATIN | LOVASTATIN | 20MG | TABLET / ORAL | AB | | 2001-12-17 |
| A075828-003 | LOVASTATIN | LOVASTATIN | 40MG | TABLET / ORAL | AB | | 2001-12-17 |
Therapeutic equivalence codes#