Lovastatin
- Product NDC
- 45963-633
- 11-digit product format
- 459630633
- Labeler code
- 45963
- Product ID
- 45963-633_fa0b909d-8e24-416d-9674-b18bb436e657
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lovastatin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA075828
- Marketing category
- ANDA
- Marketing start
- 2001-12-17
- Marketing end
- 2021-03-31
- 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
- 0000-00-00
- 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 | 45963-633 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 45963-633 | 45963-633-01 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 45963-633 | 45963-633-04 | 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#
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] | 26 | |
| LOVASTATIN | ACTIVE MOIETY | 9LHU78OQFD | LOVASTATIN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 26 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | LOVASTATIN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 26 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LOVASTATIN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 26 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LOVASTATIN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 26 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LOVASTATIN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 26 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LOVASTATIN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 26 | |
| LOVASTATIN | ACTIVE INGREDIENT | 9LHU78OQFD | LOVASTATIN TABLET [ACTAVIS INC.] | 12 | |
| LOVASTATIN | ACTIVE MOIETY | 9LHU78OQFD | LOVASTATIN TABLET [ACTAVIS INC.] | 12 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | LOVASTATIN TABLET [ACTAVIS INC.] | 12 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LOVASTATIN TABLET [ACTAVIS INC.] | 12 | |
| D&C RED NO. 30 | INACTIVE INGREDIENT | 2S42T2808B | LOVASTATIN TABLET [ACTAVIS INC.] | 12 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | LOVASTATIN TABLET [ACTAVIS INC.] | 12 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LOVASTATIN TABLET [ACTAVIS INC.] | 12 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LOVASTATIN TABLET [ACTAVIS INC.] | 12 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LOVASTATIN TABLET [ACTAVIS INC.] | 12 | |
| LOVASTATIN | ACTIVE INGREDIENT | 9LHU78OQFD | LOVASTATIN TABLET [AMERICAN HEALTH PACKAGING] | 5 | |
| LOVASTATIN | ACTIVE MOIETY | 9LHU78OQFD | LOVASTATIN TABLET [AMERICAN HEALTH PACKAGING] | 5 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | LOVASTATIN TABLET [AMERICAN HEALTH PACKAGING] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LOVASTATIN TABLET [AMERICAN HEALTH PACKAGING] | 5 | |
| D&C RED NO. 30 | INACTIVE INGREDIENT | 2S42T2808B | LOVASTATIN TABLET [AMERICAN HEALTH PACKAGING] | 5 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | LOVASTATIN TABLET [AMERICAN HEALTH PACKAGING] | 5 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LOVASTATIN TABLET [AMERICAN HEALTH PACKAGING] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LOVASTATIN TABLET [AMERICAN HEALTH PACKAGING] | 5 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LOVASTATIN TABLET [AMERICAN HEALTH PACKAGING] | 5 | |
| LOVASTATIN | ACTIVE INGREDIENT | 9LHU78OQFD | LOVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] | 2 | |
| LOVASTATIN | ACTIVE MOIETY | 9LHU78OQFD | LOVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] | 2 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | LOVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LOVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] | 2 | |
| D&C RED NO. 30 | INACTIVE INGREDIENT | 2S42T2808B | LOVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] | 2 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | LOVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LOVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LOVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LOVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] | 2 | |
| LOVASTATIN | ACTIVE INGREDIENT | 9LHU78OQFD | LOVASTATIN TABLET [NORTHWIND PHARMACEUTICALS, LLC] | 1 | |
| LOVASTATIN | ACTIVE INGREDIENT | 9LHU78OQFD | LOVASTATIN TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] | 1 | |
| LOVASTATIN | ACTIVE MOIETY | 9LHU78OQFD | LOVASTATIN TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] | 1 | |
| LOVASTATIN | ACTIVE MOIETY | 9LHU78OQFD | LOVASTATIN TABLET [NORTHWIND PHARMACEUTICALS, LLC] | 1 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | LOVASTATIN TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LOVASTATIN TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LOVASTATIN TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LOVASTATIN TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LOVASTATIN TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] | 1 | |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 45963-633-04 | 45963063304 | 500 TABLET in 1 BOTTLE (45963-633-04) | 500 tablet | 2001-12-17 | 2021-03-31 | No | No | Current |