Lovastatin
- Product NDC
- 68788-9180
- 11-digit product format
- 687889180
- Labeler code
- 68788
- Product ID
- 68788-9180_9069b3a6-2840-44b0-994d-797c038a1f38
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lovastatin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc
- Application
- ANDA075828
- Marketing category
- ANDA
- Marketing start
- 2005-10-27
- 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
- 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.
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 Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-9180-3 | Lovastatin | 30 in 1 BOTTLE, DISPENSING | TABLET | 30 | | 4 |
| 68788-9180-6 | Lovastatin | 60 in 1 BOTTLE, DISPENSING | TABLET | 60 | | 4 |
| 68788-9180-8 | Lovastatin | 120 in 1 BOTTLE, DISPENSING | TABLET | 120 | | 4 |
| 68788-9180-9 | Lovastatin | 90 in 1 BOTTLE, DISPENSING | TABLET | 90 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LOVASTATIN | ACTIVE INGREDIENT | 9LHU78OQFD | LOVASTATIN TABLET [PREFERRED PHARMACEUTICALS, INC] | 3 | |
| LOVASTATIN | ACTIVE MOIETY | 9LHU78OQFD | LOVASTATIN TABLET [PREFERRED PHARMACEUTICALS, INC] | 3 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | LOVASTATIN TABLET [PREFERRED PHARMACEUTICALS, INC] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LOVASTATIN TABLET [PREFERRED PHARMACEUTICALS, INC] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LOVASTATIN TABLET [PREFERRED PHARMACEUTICALS, INC] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LOVASTATIN TABLET [PREFERRED PHARMACEUTICALS, INC] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LOVASTATIN TABLET [PREFERRED PHARMACEUTICALS, INC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-9180 | LOVASTATIN TABLET [PREFERRED PHARMACEUTICALS, INC] | 4 | Legacy NDC, 4 package rows | 20161230_50b7fc3e-de79-4b08-a2b7-b05110ec70fb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 68788-9180-3 | 68788918003 | 30 in 1 BOTTLE, DISPENSING | Historical |
| 68788-9180-6 | 68788918006 | 60 in 1 BOTTLE, DISPENSING | Historical |
| 68788-9180-8 | 68788918008 | 120 in 1 BOTTLE, DISPENSING | Historical |
| 68788-9180-9 | 68788918009 | 90 in 1 BOTTLE, DISPENSING | Historical |