Pitavastatin
- Product NDC
- 65862-812
- 11-digit product format
- 658620812
- Labeler code
- 65862
- Product ID
- 65862-812_9a71c5a7-aaf8-4650-aba4-da6ba84d03a7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pitavastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA206015
- 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
- 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 |
|---|
| 65862-812-05 | Pitavastatin | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 6 |
| 65862-812-90 | Pitavastatin | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-812 | PITAVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 6 | Current NDC, 2 package rows | 20240425_a52401eb-a822-475b-a40d-7b8acde2ae1a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 65862-812-05 | 65862081205 | 500 TABLET, FILM COATED in 1 BOTTLE (65862-812-05) | 2023-11-02 | No | No | Historical |
| 65862-812-90 | 65862081290 | 90 TABLET, FILM COATED in 1 BOTTLE (65862-812-90) | 2023-11-02 | No | No | Historical |