Lovastatin
- Product NDC
- 50436-6601
- 11-digit product format
- 504366601
- Labeler code
- 50436
- Product ID
- 50436-6601_f81263f5-8b26-42a7-ade3-efc111d2e04b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lovastatin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- ANDA075991
- Marketing category
- ANDA
- Marketing start
- 2002-11-25
- Marketing end
- 0000-00-00
- Substance
- LOVASTATIN
- Active strength
- 20 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 |
|---|---|---|---|---|---|
| 50436-6601-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-11cd-a910-e053-dadaa90a0b85 | Lovastatin Tablet USP Revision J |
| 50436-6601-3 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-11cd-a910-e053-dadaa90a0b85 | Lovastatin Tablet USP Revision J |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50436-6601-1 | Lovastatin | 30 in 1 BOTTLE | TABLET | 30 | 10 | |
| 50436-6601-3 | Lovastatin | 90 in 1 BOTTLE | TABLET | 90 | 10 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Lovastatin | ACTIVE INGREDIENT | 9LHU78OQFD | LOVASTATIN TABLET [UNIT DOSE SERVICES] | 2 | |
| Lovastatin | ACTIVE MOIETY | 9LHU78OQFD | LOVASTATIN TABLET [UNIT DOSE SERVICES] | 2 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | LOVASTATIN TABLET [UNIT DOSE SERVICES] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LOVASTATIN TABLET [UNIT DOSE SERVICES] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LOVASTATIN TABLET [UNIT DOSE SERVICES] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LOVASTATIN TABLET [UNIT DOSE SERVICES] | 2 | |
| POLOXAMER 188 | INACTIVE INGREDIENT | LQA7B6G8JG | LOVASTATIN TABLET [UNIT DOSE SERVICES] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | LOVASTATIN TABLET [UNIT DOSE SERVICES] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LOVASTATIN TABLET [UNIT DOSE SERVICES] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | LOVASTATIN TABLET [UNIT DOSE SERVICES] | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50436-6601 | LOVASTATIN TABLET [UNIT DOSE SERVICES] | 10 | Legacy NDC, 2 package rows | 20190503_5c707089-fb5b-4016-8ca7-11bbcfb57854.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197904 | lovastatin 20 MG Oral Tablet | PSN | 5c707089-fb5b-4016-8ca7-11bbcfb57854 | 10 |
| 197904 | lovastatin 20 MG Oral Tablet | SCD | 5c707089-fb5b-4016-8ca7-11bbcfb57854 | 10 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 50436-6601-1 | 50436660101 | 30 in 1 BOTTLE | Historical |
| 50436-6601-3 | 50436660103 | 90 in 1 BOTTLE | Historical |