Lovastatin
- Product NDC
- 0615-7685
- 11-digit product format
- 006157685
- Labeler code
- 0615
- Product ID
- 0615-7685_d7461921-fd95-4d44-80cb-b966dbf5e2eb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lovastatin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, Inc dba Vangard Labs
- Application
- ANDA075828
- Marketing category
- ANDA
- Marketing start
- 2001-12-17
- Marketing end
- 0000-00-00
- Substance
- LOVASTATIN
- 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
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 | 0615-7685 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 0615-7685 | 0615-7685-39 | 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LOVASTATIN | ACTIVE INGREDIENT | 9LHU78OQFD | LOVASTATIN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 1 | |
| LOVASTATIN | ACTIVE MOIETY | 9LHU78OQFD | LOVASTATIN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 1 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | LOVASTATIN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LOVASTATIN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | LOVASTATIN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LOVASTATIN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LOVASTATIN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LOVASTATIN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 1 | |