Rosuvastatin Calcium
- Product NDC
- 0615-8534
- 11-digit product format
- 006158534
- Labeler code
- 0615
- Product ID
- 0615-8534_9feb1012-a261-4a00-a854-26cff1a6f517
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin Calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA079170
- Marketing category
- ANDA
- Marketing start
- 2016-07-19
- 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 |
|---|
| 0615-8534-05 | Rosuvastatin Calcium | 15 in 1 BLISTER PACK | TABLET, FILM COATED | 15 | | 1 |
| 0615-8534-39 | Rosuvastatin Calcium | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8534 | ROSUVASTATIN CALCIUM TABLET, FILM COATED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 1 | Current NDC, 2 package rows | 20241004_d84f596d-8b99-419c-9a02-4b5e26aeaea8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0615-8534-05 | 00615853405 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8534-05) | 2024-09-13 | No | No | Current |
| 0615-8534-39 | 00615853439 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8534-39) | 2024-09-13 | No | No | Current |