Lovastatin
- Product NDC
- 53002-1385
- 11-digit product format
- 530021385
- Labeler code
- 53002
- Product ID
- 53002-1385_5c6704b8-e965-449b-bdf9-c7cada185cf0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lovastatin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA078296
- Marketing category
- ANDA
- Marketing start
- 2007-11-01
- Marketing end
- 0000-00-00
- 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 53002-1385-0 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-f3e8-f424-e053-dadaa90a57ce | LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only |
| 53002-1385-3 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-f3e8-f424-e053-dadaa90a57ce | LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only |
| 53002-1385-6 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-f3e8-f424-e053-dadaa90a57ce | LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only |
| 53002-1385-0 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d0-f3e8-f424-e053-dadaa90a57ce | LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only |
| 53002-1385-3 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d0-f3e8-f424-e053-dadaa90a57ce | LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only |
| 53002-1385-6 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d0-f3e8-f424-e053-dadaa90a57ce | LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only |
| 53002-1385-0 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-f3e8-f424-e053-dadaa90a57ce | LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only |
| 53002-1385-3 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-f3e8-f424-e053-dadaa90a57ce | LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only |
| 53002-1385-6 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-f3e8-f424-e053-dadaa90a57ce | LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only |
| 53002-1385-0 | 2020-12-15 | C162847 | 48780-1 | 9d75b9d0-f3e8-f424-e053-dadaa90a57ce | LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only |
| 53002-1385-3 | 2020-12-15 | C162847 | 48780-1 | 9d75b9d0-f3e8-f424-e053-dadaa90a57ce | LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only |
| 53002-1385-6 | 2020-12-15 | C162847 | 48780-1 | 9d75b9d0-f3e8-f424-e053-dadaa90a57ce | LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only |
| 53002-1385-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f3e8-f424-e053-dadaa90a57ce | LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only |
| 53002-1385-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f3e8-f424-e053-dadaa90a57ce | LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only |
| 53002-1385-6 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f3e8-f424-e053-dadaa90a57ce | LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-1385-0 | Lovastatin | 100 in 1 BOTTLE | TABLET | 100 | | 5 |
| 53002-1385-3 | Lovastatin | 30 in 1 BOTTLE | TABLET | 30 | | 5 |
| 53002-1385-6 | Lovastatin | 60 in 1 BOTTLE | TABLET | 60 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-1385 | LOVASTATIN TABLET [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 3 package rows | 20230609_0d3d6373-e3e9-456b-99eb-fbfe86a9ac32.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 |
|---|
| 53002-1385-0 | 53002138500 | 100 TABLET in 1 BOTTLE (53002-1385-0) | 100 tablet | 2017-09-01 | 0000-00-00 | No | No | Current |
| 53002-1385-3 | 53002138503 | 30 TABLET in 1 BOTTLE (53002-1385-3) | 30 tablet | 2017-09-01 | 0000-00-00 | No | No | Current |
| 53002-1385-6 | 53002138506 | 60 TABLET in 1 BOTTLE (53002-1385-6) | 60 tablet | 2017-09-01 | 0000-00-00 | No | No | Current |