Rosuvastatin Calcium
- Product NDC
- 71610-233
- 11-digit product format
- 716100233
- Labeler code
- 71610
- Product ID
- 71610-233_e177d76d-1ef4-4218-9e40-07cdf617857b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin Calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA207408
- Marketing category
- ANDA
- Marketing start
- 2016-10-31
- 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
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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 83MVU38M7Q |
| Rxcui | 859419, 859747, 859751 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-233-15 | Rosuvastatin Calcium | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 3 |
| 71610-233-19 | Rosuvastatin Calcium | 3060 in 1 BOTTLE | TABLET, FILM COATED | 3060 | | 3 |
| 71610-233-45 | Rosuvastatin Calcium | 45 in 1 BOTTLE | TABLET, FILM COATED | 45 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-233 | ROSUVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | Current NDC, Legacy NDC, 3 package rows | 20230321_ab6c1601-5152-443c-98a0-876660d533e8.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 |
|---|
| 71610-233-15 | 71610023315 | 15 TABLET, FILM COATED in 1 BOTTLE (71610-233-15) | 2019-02-06 | 0000-00-00 | No | No | Current |
| 71610-233-19 | 71610023319 | 3060 TABLET, FILM COATED in 1 BOTTLE (71610-233-19) | 2023-03-17 | | No | No | Historical |
| 71610-233-45 | 71610023345 | 45 TABLET, FILM COATED in 1 BOTTLE (71610-233-45) | 2019-02-06 | 0000-00-00 | No | No | Current |