Lovastatin
- Product NDC
- 35356-885
- 11-digit product format
- 353560885
- Labeler code
- 35356
- Product ID
- 35356-885_33efd94e-b7e3-4064-94ff-56afee7ead1b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lovastatin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lake Erie Medical DBA Quality Care Products LLC
- Application
- ANDA075828
- Marketing category
- ANDA
- Marketing start
- 2001-12-17
- Marketing end
- 0000-00-00
- Substance
- LOVASTATIN
- Active strength
- 20 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.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 35356-885 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 35356-885 | 35356-885-30 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 35356-885 | 35356-885-60 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 35356-885 | 35356-885-90 | D | Discontinued by firm | | 2026-07-31 |
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#