pitavastatin calcium
- Product NDC
- 68382-481
- 11-digit product format
- 683820481
- Labeler code
- 68382
- Product ID
- 68382-481_f34ff300-0613-4b94-9fcf-475d6494ea7e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pitavastatin calcium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA206047
- Marketing category
- ANDA
- Marketing start
- 2023-11-02
- Substance
- PITAVASTATIN CALCIUM
- Active strength
- 1 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 calcium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PITAVASTATIN CALCIUM | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | IYD54XEG3W |
| Rxcui | 861643, 861648, 861652 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68382-481-16 | pitavastatin calcium | 90 in 1 BOTTLE | TABLET | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-481 | PITAVASTATIN CALCIUM TABLET [ZYDUS PHARMACEUTICALS USA INC.] | 5 | Current NDC, 1 package rows | 20240329_c35e747e-10ac-4a76-bce6-187618fc64f9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68382-481-16 | 68382048116 | 90 TABLET in 1 BOTTLE (68382-481-16) | 90 tablet | 2023-11-02 | No | No | Current |