LOVASTATIN
- Product NDC
- 54458-938
- 11-digit product format
- 544580938
- Labeler code
- 54458
- Product ID
- 54458-938_409cb06e-21c2-4462-b1e8-480e30882c05
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LOVASTATIN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- International Laboratories, LLC
- Application
- ANDA078296
- Marketing category
- ANDA
- Marketing start
- 2010-03-22
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
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 [INTERNATIONAL LABS, INC.] | 20 | |
| LOVASTATIN | ACTIVE MOIETY | 9LHU78OQFD | LOVASTATIN TABLET [INTERNATIONAL LABS, INC.] | 20 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | LOVASTATIN TABLET [INTERNATIONAL LABS, INC.] | 20 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | LOVASTATIN TABLET [INTERNATIONAL LABS, INC.] | 20 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LOVASTATIN TABLET [INTERNATIONAL LABS, INC.] | 20 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | LOVASTATIN TABLET [INTERNATIONAL LABS, INC.] | 20 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | LOVASTATIN TABLET [INTERNATIONAL LABS, INC.] | 20 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | LOVASTATIN TABLET [INTERNATIONAL LABS, INC.] | 20 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LOVASTATIN TABLET [INTERNATIONAL LABS, INC.] | 20 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LOVASTATIN TABLET [INTERNATIONAL LABS, INC.] | 20 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LOVASTATIN TABLET [INTERNATIONAL LABS, INC.] | 20 | |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 54458-938-10 | 54458093810 | 30 TABLET in 1 BLISTER PACK (54458-938-10) | 30 tablet | 2010-03-22 | 0000-00-00 | No | No | Current |
| 54458-938-16 | 54458093816 | 30 TABLET in 1 BOTTLE (54458-938-16) | 30 tablet | 2017-04-07 | 0000-00-00 | No | No | Current |