Lovastatin
- Product NDC
- 43063-493
- 11-digit product format
- 430630493
- Labeler code
- 43063
- Product ID
- 43063-493_e6892ae2-118f-fb69-e053-2995a90a1711
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lovastatin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA078296
- Marketing category
- ANDA
- Marketing start
- 2008-03-14
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LOVASTATIN | ACTIVE INGREDIENT | 9LHU78OQFD | LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| LOVASTATIN | ACTIVE MOIETY | 9LHU78OQFD | LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| STARCH, PREGELATINIZED CORN | INACTIVE INGREDIENT | O8232NY3SJ | LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-493 | LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 16 | Legacy NDC | 20240508_84e823a7-ddb3-46de-a271-ad6b5e72f7eb.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43063-493-30 | 43063049330 | 30 TABLET in 1 BOTTLE, PLASTIC (43063-493-30) | 30 tablet | 2013-11-15 | 0000-00-00 | No | No | Current |
| 43063-493-90 | 43063049390 | 90 TABLET in 1 BOTTLE, PLASTIC (43063-493-90) | 90 tablet | 2013-11-15 | 0000-00-00 | No | No | Current |