Lovastatin
- Product NDC
- 21695-536
- 11-digit product format
- 216950536
- Labeler code
- 21695
- Product ID
- 21695-536_347c802f-4ea9-41d4-80d6-e4a183f22179
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lovastatin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA078296
- Marketing category
- ANDA
- Marketing start
- 2007-11-01
- Marketing end
- 0000-00-00
- Substance
- LOVASTATIN
- Active strength
- 40 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
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dc9a5fb6-14e2-1cc8-a567-a781fd1f0212 | Product name | 1 | 20140508 |
| f1ae760e-e8ec-b0b4-fb1b-2db7c49fcec5 | Product name | 1 | 20140508 |
| fecc3d5d-ff9a-60ad-1a3a-6cb9b21df758 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-536-30 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4935-48b1-e053-8cdaa90a720a | LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only |
| 21695-536-90 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4935-48b1-e053-8cdaa90a720a | LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-536-30 | Lovastatin | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 21695-536-90 | Lovastatin | 90 in 1 BOTTLE | TABLET | 90 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-536-90 | EA - Each | 21695-536 | 78509dd7-4fc5-401d-ab5a-375306de506b | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| LOVASTATIN | ACTIVE INGREDIENT | 9LHU78OQFD | LOVASTATIN TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| LOVASTATIN | ACTIVE MOIETY | 9LHU78OQFD | LOVASTATIN TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | LOVASTATIN TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | LOVASTATIN TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LOVASTATIN TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | LOVASTATIN TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | LOVASTATIN TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LOVASTATIN TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LOVASTATIN TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LOVASTATIN TABLET [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197903 | lovastatin 10 MG Oral Tablet | PSN | 347c802f-4ea9-41d4-80d6-e4a183f22179 | 1 |
| 197904 | lovastatin 20 MG Oral Tablet | PSN | 347c802f-4ea9-41d4-80d6-e4a183f22179 | 1 |
| 197905 | lovastatin 40 MG Oral Tablet | PSN | 347c802f-4ea9-41d4-80d6-e4a183f22179 | 1 |
| 197903 | lovastatin 10 MG Oral Tablet | SCD | 347c802f-4ea9-41d4-80d6-e4a183f22179 | 1 |
| 197904 | lovastatin 20 MG Oral Tablet | SCD | 347c802f-4ea9-41d4-80d6-e4a183f22179 | 1 |
| 197905 | lovastatin 40 MG Oral Tablet | SCD | 347c802f-4ea9-41d4-80d6-e4a183f22179 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-536-30 | 21695053630 | 30 in 1 BOTTLE | Historical |
| 21695-536-90 | 21695053690 | 90 in 1 BOTTLE | Historical |