Lovastatin
- Product NDC
- 43063-548
- 11-digit product format
- 430630548
- Labeler code
- 43063
- Product ID
- 43063-548_2f3a8f82-8530-3a64-e063-6294a90aa0b0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lovastatin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA075991
- Marketing category
- ANDA
- Marketing start
- 2002-11-25
- Substance
- LOVASTATIN
- Active strength
- 40 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lovastatin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LOVASTATIN | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9LHU78OQFD |
| Rxcui | 197905 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43063-548-14 | Lovastatin | 14 in 1 BOTTLE, PLASTIC | TABLET | 14 | | 26 |
| 43063-548-30 | Lovastatin | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 26 |
| 43063-548-90 | Lovastatin | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 26 |
| 43063-548-93 | Lovastatin | 180 in 1 BOTTLE, PLASTIC | TABLET | 180 | | 26 |
| 43063-548-95 | Lovastatin | 1000 in 1 BOTTLE, PLASTIC | TABLET | 1000 | | 26 |
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.] | 8 | |
| LOVASTATIN | ACTIVE MOIETY | 9LHU78OQFD | LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 8 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 8 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 8 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 8 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 8 | |
| POLOXAMER 188 | INACTIVE INGREDIENT | LQA7B6G8JG | LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 8 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 8 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 8 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 8 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-548 | LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 26 | Current NDC, Legacy NDC, 5 package rows | 20250305_eea93a4b-f804-4b9c-aabf-e906f03c1e80.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43063-548-14 | 43063054814 | 14 TABLET in 1 BOTTLE, PLASTIC (43063-548-14) | 14 tablet | 2014-11-15 | 0000-00-00 | No | No | Current |
| 43063-548-30 | 43063054830 | 30 TABLET in 1 BOTTLE, PLASTIC (43063-548-30) | 30 tablet | 2014-11-15 | 0000-00-00 | No | No | Current |
| 43063-548-90 | 43063054890 | 90 TABLET in 1 BOTTLE, PLASTIC (43063-548-90) | 90 tablet | 2014-11-15 | 0000-00-00 | No | No | Current |
| 43063-548-93 | 43063054893 | 180 TABLET in 1 BOTTLE, PLASTIC (43063-548-93) | 180 tablet | 2014-12-24 | 0000-00-00 | No | No | Current |
| 43063-548-95 | 43063054895 | 1000 TABLET in 1 BOTTLE, PLASTIC (43063-548-95) | 1000 tablet | 2022-09-16 | 0000-00-00 | No | No | Current |