Pitavastatin
- Product NDC
- 0832-6049
- 11-digit product format
- 008326049
- Labeler code
- 0832
- Product ID
- 0832-6049_266944ba-7e94-48c6-e063-6394a90adc2e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pitavastatin Calcium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Upsher-Smith Laboratories, LLC
- Application
- ANDA205955
- Marketing category
- ANDA
- Marketing start
- 2023-11-02
- Substance
- PITAVASTATIN CALCIUM
- Active strength
- 2 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pitavastatin
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PITAVASTATIN CALCIUM | 2 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | IYD54XEG3W |
| Rxcui | 861643, 861648, 861652 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a3b6a39e-87bf-f126-1bde-83d69cbf558b | Product name | 3 | 20250219 |
| de94155c-7345-40be-9a5b-89d04e1ac565 | Product name | 1 | 20190313 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0832-6049-90 | Pitavastatin | 90 in 1 BOTTLE | TABLET | 90 | 7 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 861643 | pitavastatin calcium 1 MG Oral Tablet | PSN | 9ad1ecb9-822d-47c1-9f6f-6f771fa0f924 | 7 |
| 861648 | pitavastatin calcium 2 MG Oral Tablet | PSN | 9ad1ecb9-822d-47c1-9f6f-6f771fa0f924 | 7 |
| 861652 | pitavastatin calcium 4 MG Oral Tablet | PSN | 9ad1ecb9-822d-47c1-9f6f-6f771fa0f924 | 7 |
| 861643 | pitavastatin calcium 1 MG Oral Tablet | SCD | 9ad1ecb9-822d-47c1-9f6f-6f771fa0f924 | 7 |
| 861648 | pitavastatin calcium 2 MG Oral Tablet | SCD | 9ad1ecb9-822d-47c1-9f6f-6f771fa0f924 | 7 |
| 861652 | pitavastatin calcium 4 MG Oral Tablet | SCD | 9ad1ecb9-822d-47c1-9f6f-6f771fa0f924 | 7 |
| 861643 | pitavastatin 1 MG (as pitavastatin calcium 1.045 MG) Oral Tablet | SY | 9ad1ecb9-822d-47c1-9f6f-6f771fa0f924 | 7 |
| 861648 | pitavastatin 2 MG (as pitavastatin calcium 2.09 MG) Oral Tablet | SY | 9ad1ecb9-822d-47c1-9f6f-6f771fa0f924 | 7 |
| 861652 | pitavastatin 4 MG (as pitavastatin calcium 4.18 MG) Oral Tablet | SY | 9ad1ecb9-822d-47c1-9f6f-6f771fa0f924 | 7 |
| 861643 | pitavastatin calcium 1 MG Oral Tablet | PSN | 2d5a1b78-4aa6-537b-e063-6394a90a522f | 1 |
| 861648 | pitavastatin calcium 2 MG Oral Tablet | PSN | 2d5a1b78-4aa6-537b-e063-6394a90a522f | 1 |
| 861652 | pitavastatin calcium 4 MG Oral Tablet | PSN | 2d5a1b78-4aa6-537b-e063-6394a90a522f | 1 |
| 861643 | pitavastatin calcium 1 MG Oral Tablet | SCD | 2d5a1b78-4aa6-537b-e063-6394a90a522f | 1 |
| 861648 | pitavastatin calcium 2 MG Oral Tablet | SCD | 2d5a1b78-4aa6-537b-e063-6394a90a522f | 1 |
| 861652 | pitavastatin calcium 4 MG Oral Tablet | SCD | 2d5a1b78-4aa6-537b-e063-6394a90a522f | 1 |
| 861643 | pitavastatin 1 MG (as pitavastatin calcium 1.045 MG) Oral Tablet | SY | 2d5a1b78-4aa6-537b-e063-6394a90a522f | 1 |
| 861648 | pitavastatin 2 MG (as pitavastatin calcium 2.09 MG) Oral Tablet | SY | 2d5a1b78-4aa6-537b-e063-6394a90a522f | 1 |
| 861652 | pitavastatin 4 MG (as pitavastatin calcium 4.18 MG) Oral Tablet | SY | 2d5a1b78-4aa6-537b-e063-6394a90a522f | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0832-6049-90 | 00832604990 | 90 TABLET in 1 BOTTLE (0832-6049-90) | 90 tablet | 2023-11-02 | No | No | Historical |