Rosuvastatin Calcium
- Product NDC
- 47335-583
- 11-digit product format
- 473350583
- Labeler code
- 47335
- Product ID
- 47335-583_1fa645cf-c870-4b0b-b6b3-53c2f1c32a6f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin Calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA079169
- Marketing category
- ANDA
- Marketing start
- 2021-03-01
- Substance
- ROSUVASTATIN CALCIUM
- Active strength
- 10 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
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 47335-583-18 | Rosuvastatin Calcium | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 16 |
| 47335-583-81 | Rosuvastatin Calcium | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 16 |
| 47335-583-83 | Rosuvastatin Calcium | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47335-583 | ROSUVASTATIN CALCIUM TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 16 | Current NDC, Legacy NDC, 3 package rows | 20240831_ef243da2-d388-40e4-a1cb-a5e0688efc49.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 47335-583-18 | 47335058318 | 1000 TABLET, FILM COATED in 1 BOTTLE (47335-583-18) | 2021-03-01 | | No | No | Historical |
| 47335-583-81 | 47335058381 | 90 TABLET, FILM COATED in 1 BOTTLE (47335-583-81) | 2021-03-01 | 0000-00-00 | No | No | Current |
| 47335-583-83 | 47335058383 | 30 TABLET, FILM COATED in 1 BOTTLE (47335-583-83) | 2023-06-23 | | No | No | Historical |