Active ingredient
Rosuvastatin
279 finished FDA listings contain Rosuvastatin as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ROSUVASTATIN, ROSUVASTATIN CALCIUM
- Dosage forms
- Tablet, Tablet, Coated, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 47
- Strengths listed
- 10 mg/1 · 20 mg/1 · 40 mg/1 · 5 mg/1
- Brand names in FDA listings
- Crestor
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 301542
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 021366 | ASTRAZENECA | 2003-08-12 | 4 |
| ANDA 079168 | CHARTWELL RX | 2016-07-19 | 4 |
| ANDA 079170 | AUROBINDO PHARMA LTD | 2016-07-19 | 33 |
| ANDA 079172 | GLENMARK SPECLT | 2016-07-19 | 31 |
| ANDA 207062 | RENATA | 2016-10-31 | 8 |
| ANDA 207752 | BIOCON PHARMA | 2016-10-31 | 19 |
| ANDA 206434 | ACCORD HLTHCARE | 2016-10-31 | 14 |
| ANDA 207408 | CHANGZHOU PHARM | 2016-10-31 | 14 |
| ANDA 207616 | HETERO LABS LTD V | 2016-10-31 | 13 |
| ANDA 201619 | TORRENT | 2016-10-31 | 6 |
| ANDA 207453 | CADILA PHARMS LTD | 2016-11-23 | 4 |
| ANDA 206465 | ALKEM LABS LTD | 2017-03-21 | 16 |
| ANDA 208898 | MSN | 2017-11-22 | 33 |
| ANDA 206513 | ZHEJIANG JINGXIN | 2019-03-01 | 4 |
| ANDA 207626 | UMEDICA | 2019-04-09 | 23 |
| ANDA 206381 | SCIEGEN PHARMS | 2019-04-24 | 33 |
| ANDA 207375 | SHANDONG | 2019-05-07 | 4 |
| ANDA 212059 | ZHEJIANG YONGTAI | 2019-11-04 | 4 |
| ANDA 210667 | SUNSHINE | 2020-04-01 | 4 |
| ANDA 207296 | MACLEODS PHARMS | 2024-11-06 | 4 |
| ANDA 206603 | MANKIND PHARMA | 2025-05-16 | 4 |
Official labeling on DailyMed
- ROSUVASTATIN TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] · version 10 · 2026-09-10
- ROSUVASTATIN CALCIUM TABLET, FILM COATED [REMEDYREPACK INC.] · version 4 · 2026-09-10
- ROSUVASTATIN TABLET, FILM COATED [REMEDYREPACK INC.] · version 4 · 2026-09-07
- ROSUVASTATIN TABLET, FILM COATED [REMEDYREPACK INC.] · version 6 · 2026-09-07
- ROSUVASTATIN TABLET, FILM COATED [REMEDYREPACK INC.] · version 6 · 2026-09-07
- ROSUVASTATIN CALCIUM TABLET [TORRENT PHARMACEUTICALS LIMITED] · version 9 · 2026-09-03
- ROSUVASTATIN CALCIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] · version 26 · 2026-09-02
- ROSUVASTATIN CALCIUM TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.] · version 16 · 2026-09-02
- ROSUVASTATIN CALCIUM TABLET, FILM COATED [REMEDYREPACK INC.] · version 3 · 2026-09-02
- ROSUVASTATIN CALCIUM TABLET, FILM COATED [REMEDYREPACK INC.] · version 3 · 2026-09-02
- ROSUVASTATIN TABLET, FILM COATED [REMEDYREPACK INC.] · version 4 · 2026-08-31
- ROSUVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] · version 3 · 2026-08-31
Showing the 12 most recent of 173 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.