Lovastatin
- Product NDC
- 63629-3583
- 11-digit product format
- 636293583
- Labeler code
- 63629
- Product ID
- 63629-3583_eb5b4e62-2714-4a98-895b-ef01ae1bbfb4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lovastatin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA075991
- Marketing category
- ANDA
- Marketing start
- 2002-11-25
- 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
- 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 |
|---|---|
| LOVASTATIN | 10 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 9LHU78OQFD |
| Rxcui | 197903 |
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 |
|---|---|---|---|---|---|
| 63629-3583-1 | 2020-02-25 | C162847 | 48780-1 | 9d75b9d0-71b6-f424-e053-dadaa90a57ce | Lovastatin Tablet USP Revision M |
| 63629-3583-2 | 2020-02-25 | C162847 | 48780-1 | 9d75b9d0-71b6-f424-e053-dadaa90a57ce | Lovastatin Tablet USP Revision M |
| 63629-3583-3 | 2020-02-25 | C162847 | 48780-1 | 9d75b9d0-71b6-f424-e053-dadaa90a57ce | Lovastatin Tablet USP Revision M |
| 63629-3583-4 | 2020-02-25 | C162847 | 48780-1 | 9d75b9d0-71b6-f424-e053-dadaa90a57ce | Lovastatin Tablet USP Revision M |
| 63629-3583-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-71b6-f424-e053-dadaa90a57ce | Lovastatin Tablet USP Revision M |
| 63629-3583-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-71b6-f424-e053-dadaa90a57ce | Lovastatin Tablet USP Revision M |
| 63629-3583-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-71b6-f424-e053-dadaa90a57ce | Lovastatin Tablet USP Revision M |
| 63629-3583-4 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-71b6-f424-e053-dadaa90a57ce | Lovastatin Tablet USP Revision M |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63629-3583-1 | Lovastatin | 30 in 1 BOTTLE | TABLET | 30 | 1006 | |
| 63629-3583-2 | Lovastatin | 60 in 1 BOTTLE | TABLET | 60 | 1006 | |
| 63629-3583-3 | Lovastatin | 90 in 1 BOTTLE | TABLET | 90 | 1006 | |
| 63629-3583-4 | Lovastatin | 100 in 1 BOTTLE | TABLET | 100 | 1006 | |
| 63629-3583-5 | Lovastatin | 20 in 1 BOTTLE | TABLET | 20 | 1006 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63629-3583-1 | EA - Each | 63629-3583 | ea8a8008-6e49-4ffd-9983-5062e2a035ae | 1 | 2015-05-05 |
| 63629-3583-2 | EA - Each | 63629-3583 | b303af46-eb05-4e9c-b788-af74ef5a2ce6 | 1 | 2015-05-05 |
| 63629-3583-3 | EA - Each | 63629-3583 | a28e0e05-8e17-42ce-b661-d2b8093aee3d | 1 | 2015-10-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| LOVASTATIN | ACTIVE INGREDIENT | 9LHU78OQFD | LOVASTATIN TABLET [BRYANT RANCH PREPACK] | 1000 | |
| LOVASTATIN | ACTIVE MOIETY | 9LHU78OQFD | LOVASTATIN TABLET [BRYANT RANCH PREPACK] | 1000 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | LOVASTATIN TABLET [BRYANT RANCH PREPACK] | 1000 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LOVASTATIN TABLET [BRYANT RANCH PREPACK] | 1000 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LOVASTATIN TABLET [BRYANT RANCH PREPACK] | 1000 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LOVASTATIN TABLET [BRYANT RANCH PREPACK] | 1000 | |
| POLOXAMER 188 | INACTIVE INGREDIENT | LQA7B6G8JG | LOVASTATIN TABLET [BRYANT RANCH PREPACK] | 1000 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | LOVASTATIN TABLET [BRYANT RANCH PREPACK] | 1000 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LOVASTATIN TABLET [BRYANT RANCH PREPACK] | 1000 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | LOVASTATIN TABLET [BRYANT RANCH PREPACK] | 1000 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197903 | lovastatin 10 MG Oral Tablet | PSN | 7fd9d5c7-8025-4049-8b5b-ae3d22db507f | 1006 |
| 197903 | lovastatin 10 MG Oral Tablet | SCD | 7fd9d5c7-8025-4049-8b5b-ae3d22db507f | 1006 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63629-3583-1 | 63629358301 | 30 TABLET in 1 BOTTLE (63629-3583-1) | 30 tablet | 2007-06-28 | 0000-00-00 | No | No | Current |
| 63629-3583-2 | 63629358302 | 60 TABLET in 1 BOTTLE (63629-3583-2) | 60 tablet | 2018-04-27 | 0000-00-00 | No | No | Current |
| 63629-3583-3 | 63629358303 | 90 TABLET in 1 BOTTLE (63629-3583-3) | 90 tablet | 2011-08-09 | 0000-00-00 | No | No | Current |
| 63629-3583-4 | 63629358304 | 100 TABLET in 1 BOTTLE (63629-3583-4) | 100 tablet | 2012-01-03 | 0000-00-00 | No | No | Current |
| 63629-3583-5 | 63629358305 | 20 TABLET in 1 BOTTLE (63629-3583-5) | 20 tablet | 2018-12-26 | 0000-00-00 | No | No | Current |