Pitavastatin
- Product NDC
- 65162-031
- 11-digit product format
- 651620031
- Labeler code
- 65162
- Product ID
- 65162-031_ab7d1d71-229c-4528-9c2d-59d268c48c25
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pitavastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA205961
- Marketing category
- ANDA
- Marketing start
- 2024-08-21
- Substance
- PITAVASTATIN CALCIUM
- Active strength
- 4 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 | 4 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 |
|---|
| 65162-031-03 | Pitavastatin | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 12 |
| 65162-031-09 | Pitavastatin | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 12 |
| 65162-031-50 | Pitavastatin | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-031 | PITAVASTATIN TABLET, FILM COATED [AMNEAL PHARMACEUTICALS LLC] | 12 | Current NDC, 3 package rows | 20240825_7fbfcc0c-9251-456d-a525-e62cfd8abd4b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 65162-031-03 | 65162003103 | 30 TABLET, FILM COATED in 1 BOTTLE (65162-031-03) | 2024-08-21 | No | No | Current |
| 65162-031-09 | 65162003109 | 90 TABLET, FILM COATED in 1 BOTTLE (65162-031-09) | 2024-08-21 | No | No | Current |
| 65162-031-50 | 65162003150 | 500 TABLET, FILM COATED in 1 BOTTLE (65162-031-50) | 2024-08-21 | No | No | Current |