pitavastatin calcium
- Product NDC
- 72603-479
- 11-digit product format
- 726030479
- Labeler code
- 72603
- Product ID
- 72603-479_27e1ba97-23bf-fc12-e063-6394a90a1699
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pitavastatin calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NorthStar RxLLC
- Application
- ANDA205977
- Marketing category
- ANDA
- Marketing start
- 2024-12-01
- Substance
- PITAVASTATIN CALCIUM
- Active strength
- 2.09 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 | 2.09 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | IYD54XEG3W |
| Rxcui | 861648, 861652 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72603-479-01 | pitavastatin calcium | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72603-479 | PITAVASTATIN CALCIUM (PITAVASTATIN CALCIUM) TABLET, FILM COATED [NORTHSTAR RXLLC] | 1 | Current NDC, 1 package rows | 20241202_98e3f1df-5b38-4169-a340-adb145eac459.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72603-479-01 | 72603047901 | 90 TABLET, FILM COATED in 1 BOTTLE (72603-479-01) | 2024-12-01 | No | No | Historical |