Rosuvastatin calcium
- Product NDC
- 71610-133
- 11-digit product format
- 716100133
- Labeler code
- 71610
- Product ID
- 71610-133_5872733a-20c5-48d1-8e27-79d914131f7d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin Calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA207752
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-133-15 | Rosuvastatin calcium | 15 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 15 | | 1 |
| 71610-133-30 | Rosuvastatin calcium | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 1 |
| 71610-133-45 | Rosuvastatin calcium | 45 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 45 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-133 | ROSUVASTATIN CALCIUM (ROSUVASTATIN CALCIUM ) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Current NDC, Legacy NDC, 3 package rows | 20180925_cbef0681-705c-48fd-add9-1042658ef85d.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 |
|---|
| 71610-133-15 | 71610013315 | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-133-15) | 2018-08-27 | 0000-00-00 | No | No | Current |
| 71610-133-30 | 71610013330 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-133-30) | 2018-09-04 | 0000-00-00 | No | No | Current |
| 71610-133-45 | 71610013345 | 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-133-45) | 2018-08-27 | 0000-00-00 | No | No | Current |