Pitavastatin Calcium
- Product NDC
- 0378-5055
- 11-digit product format
- 003785055
- Labeler code
- 0378
- Product ID
- 0378-5055_44bb6612-917c-4457-952a-5751ea607867
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pitavastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA206070
- 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 |
|---|
| 0378-5055-77 | Pitavastatin Calcium | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-5055 | PITAVASTATIN CALCIUM (PITAVASTATIN) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 5 | Current NDC, 1 package rows | 20240828_26b5e5e8-45cd-4a98-9af4-2d04c1130881.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0378-5055-77 | 00378505577 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5055-77) | 2023-11-02 | No | No | Historical |