Rosuvastatin Calcium
- Product NDC
- 82009-020
- 11-digit product format
- 820090020
- Labeler code
- 82009
- Product ID
- 82009-020_86597300-9b2c-44cf-9650-503f5bdbf5bb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin Calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Quallent Pharmaceuticals Health LLC
- Application
- ANDA208898
- Marketing category
- ANDA
- Marketing start
- 2022-03-09
- Substance
- ROSUVASTATIN CALCIUM
- Active strength
- 40 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Rosuvastatin Calcium
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ROSUVASTATIN CALCIUM | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 83MVU38M7Q |
| Rxcui | 859419, 859424, 859747, 859751 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82009-020-10 | Rosuvastatin Calcium | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 6 |
| 82009-020-30 | Rosuvastatin Calcium | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82009-020 | ROSUVASTATIN CALCIUM TABLET, FILM COATED [QUALLENT PHARMACEUTICALS HEALTH LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20250302_6f978191-775e-4745-9c07-99e5be888afe.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 82009-020-10 | 82009002010 | 1000 TABLET, FILM COATED in 1 BOTTLE (82009-020-10) | 2022-03-09 | 0000-00-00 | No | No | Current |
| 82009-020-30 | 82009002030 | 30 TABLET, FILM COATED in 1 BOTTLE (82009-020-30) | 2022-03-09 | 0000-00-00 | No | No | Current |