Rosuvastatin Calcium
- Product NDC
- 16714-990
- 11-digit product format
- 167140990
- Labeler code
- 16714
- Product ID
- 16714-990_af3a6349-8b25-462d-9fbf-3e95c32734df
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin Calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NorthStar RxLLC
- Application
- ANDA079172
- Marketing category
- ANDA
- Marketing start
- 2019-06-27
- Substance
- ROSUVASTATIN CALCIUM
- Active strength
- 20 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
- Rosuvastatin Calcium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ROSUVASTATIN CALCIUM | 20 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 |
|---|
| 16714-990-01 | Rosuvastatin Calcium | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-990 | ROSUVASTATIN CALCIUM TABLET, FILM COATED [NORTHSTAR RXLLC] | 7 | Current NDC, Legacy NDC, 1 package rows | 20231110_17d71c80-fade-4735-acec-60738d26dd01.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 |
|---|
| 16714-990-01 | 16714099001 | 90 TABLET, FILM COATED in 1 BOTTLE (16714-990-01) | 2019-06-27 | 0000-00-00 | No | No | Current |