Rosuvastatin Calcium
- Product NDC
- 13668-182
- 11-digit product format
- 136680182
- Labeler code
- 13668
- Product ID
- 13668-182_56bc6158-e7ab-433e-af24-090c5777e2f0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin Calcium
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Torrent Pharmaceuticals Limited
- Application
- ANDA201619
- Marketing category
- ANDA
- Marketing start
- 2016-10-31
- 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
- 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 | 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 |
|---|
| 13668-182-05 | Rosuvastatin Calcium | 500 in 1 BOTTLE | TABLET, COATED | 500 | | 18 |
| 13668-182-30 | Rosuvastatin Calcium | 30 in 1 BOTTLE | TABLET, COATED | 30 | | 18 |
| 13668-182-90 | Rosuvastatin Calcium | 90 in 1 BOTTLE | TABLET, COATED | 90 | | 18 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13668-182 | ROSUVASTATIN CALCIUM TABLET, COATED [TORRENT PHARMACEUTICALS LIMITED] | 18 | Current NDC, Legacy NDC, 3 package rows | 20240911_8c2d481f-53f2-4cf6-bd28-7d92323785cd.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 |
|---|
| 13668-182-05 | 13668018205 | 500 TABLET, COATED in 1 BOTTLE (13668-182-05) | 2016-10-31 | 0000-00-00 | No | No | Current |
| 13668-182-30 | 13668018230 | 30 TABLET, COATED in 1 BOTTLE (13668-182-30) | 2016-10-31 | 0000-00-00 | No | No | Current |
| 13668-182-74 | 13668018274 | 100 TABLET, COATED in 1 CARTON (13668-182-74) | 2016-10-31 | 0000-00-00 | No | No | Current |
| 13668-182-90 | 13668018290 | 90 TABLET, COATED in 1 BOTTLE (13668-182-90) | 2016-10-31 | 0000-00-00 | No | No | Current |