pitavastatin calcium
- Product NDC
- 31722-877
- 11-digit product format
- 317220877
- Labeler code
- 31722
- Product ID
- 31722-877_179e2267-daf5-1cab-e063-6394a90a7f0e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pitavastatin calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA205977
- Marketing category
- ANDA
- Marketing start
- 2024-04-30
- Substance
- PITAVASTATIN CALCIUM
- Active strength
- 4.18 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 | 4.18 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 |
|---|
| 31722-877-90 | 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 |
|---|
| 31722-877 | PITAVASTATIN CALCIUM (PITAVASTATIN CALCIUM) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 1 | Current NDC, 1 package rows | 20240507_e9622824-cee5-49d7-9273-f18b9cc176fd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 31722-877-90 | 31722087790 | 90 TABLET, FILM COATED in 1 BOTTLE (31722-877-90) | 2024-04-30 | No | No | Historical |