Lovastatin
- Product NDC
- 55289-692
- 11-digit product format
- 552890692
- Labeler code
- 55289
- Product ID
- 55289-692_47e38d1a-3220-a3d3-e063-6394a90abb8f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lovastatin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA078296
- Marketing category
- ANDA
- Marketing start
- 2007-11-01
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lovastatin
- Listing expiration
- 2027-12-31
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 |
|---|
| 55289-692-14 | Lovastatin | 14 in 1 BOTTLE, PLASTIC | TABLET | 14 | | 18 |
| 55289-692-30 | Lovastatin | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 18 |
| 55289-692-90 | Lovastatin | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 18 |
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.] | 4 | |
| LOVASTATIN | ACTIVE MOIETY | 9LHU78OQFD | LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 4 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 4 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 4 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 4 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55289-692 | LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 16 | Current NDC, Legacy NDC, 3 package rows | 20240314_e75b5808-ec66-4da7-90bc-e53611aa1b34.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 |
|---|
| 55289-692-14 | 55289069214 | 14 TABLET in 1 BOTTLE, PLASTIC (55289-692-14) | 14 tablet | 2010-10-27 | 0000-00-00 | No | No | Current |
| 55289-692-30 | 55289069230 | 30 TABLET in 1 BOTTLE, PLASTIC (55289-692-30) | 30 tablet | 2010-10-27 | 0000-00-00 | No | No | Current |
| 55289-692-90 | 55289069290 | 90 TABLET in 1 BOTTLE, PLASTIC (55289-692-90) | 90 tablet | 2010-10-27 | 0000-00-00 | No | No | Current |