Rosuvastatin calcium
- Product NDC
- 68462-263
- 11-digit product format
- 684620263
- Labeler code
- 68462
- Product ID
- 68462-263_958b8936-9395-42e0-8c3b-3247a20621c4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Glenmark Pharmaceutials Inc., USA
- Application
- ANDA079172
- 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 |
|---|
| 68462-263-01 | Rosuvastatin calcium | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 13 |
| 68462-263-10 | Rosuvastatin calcium | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 13 |
| 68462-263-11 | Rosuvastatin calcium | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 13 |
| 68462-263-11 | Rosuvastatin calcium | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 13 |
| 68462-263-30 | Rosuvastatin calcium | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 13 |
| 68462-263-50 | Rosuvastatin calcium | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | | 13 |
| 68462-263-90 | Rosuvastatin calcium | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-263 | ROSUVASTATIN CALCIUM TABLET, FILM COATED [GLENMARK PHARMACEUTIALS INC., USA] | 12 | Current NDC, Legacy NDC, 7 package rows | 20240928_392657a9-955c-42c2-814c-1890ece45afa.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68462-263-01 | 68462026301 | 100 TABLET, FILM COATED in 1 BOTTLE (68462-263-01) | | 2016-07-19 | 0000-00-00 | No | No | Current |
| 68462-263-10 | 68462026310 | 1000 TABLET, FILM COATED in 1 BOTTLE (68462-263-10) | | 2016-07-19 | 0000-00-00 | No | No | Current |
| 68462-263-11 | 68462026311 | 10 BLISTER PACK in 1 CARTON (68462-263-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2016-07-19 | 0000-00-00 | No | No | Current |
| 68462-263-30 | 68462026330 | 30 TABLET, FILM COATED in 1 BOTTLE (68462-263-30) | | 2016-07-19 | 0000-00-00 | No | No | Current |
| 68462-263-50 | 68462026350 | 50 TABLET, FILM COATED in 1 BOTTLE (68462-263-50) | | 2016-07-19 | 0000-00-00 | No | No | Current |
| 68462-263-90 | 68462026390 | 90 TABLET, FILM COATED in 1 BOTTLE (68462-263-90) | | 2016-07-19 | 0000-00-00 | No | No | Current |