Active ingredient
Atorvastatin
391 finished FDA listings contain Atorvastatin as their only active ingredient; 81 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM ANHYDROUS, ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE, ATORVASTATIN CALCIUM TRIHYDRATE
- Dosage forms
- Suspension, Tablet, Tablet, Coated, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 63
- Strengths listed
- 10 mg/1 · 20 mg/1 · 20 mg/5ml · 40 mg/1 · 80 mg/1
- Brand names in FDA listings
- Atorvastatin Calcium, Lipitor
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 83367
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 020702 | UPJOHN | 1996-12-17 | 4 |
| ANDA 076477 | SUN PHARM INDS LTD | 2011-11-30 | 9 |
| ANDA 090548 | APOTEX INC | 2012-05-29 | 68 |
| ANDA 091226 | MYLAN PHARMS INC | 2012-05-29 | 14 |
| ANDA 202357 | DR REDDYS LABS LTD | 2012-07-17 | 1 |
| ANDA 091650 | DR REDDYS LABS LTD | 2012-07-17 | 3 |
| ANDA 205519 | SCIEGEN PHARMS | 2016-05-19 | 32 |
| ANDA 205300 | TEVA PHARMS USA | 2017-03-27 | 8 |
| ANDA 207687 | ACCORD HLTHCARE | 2018-03-30 | 15 |
| ANDA 209912 | GRAVITI PHARMS | 2018-06-18 | 17 |
| ANDA 206536 | ZYDUS PHARMS | 2018-11-20 | 16 |
| ANDA 209288 | ALKEM LABS LTD | 2018-12-21 | 27 |
| ANDA 211933 | MSN | 2019-02-08 | 29 |
| ANDA 204991 | LUPIN | 2019-03-06 | 9 |
| ANDA 205945 | MICRO LABS LTD INDIA | 2019-11-07 | 1 |
| ANDA 213853 | UMEDICA | 2020-08-19 | 18 |
| ANDA 214659 | DR REDDYS | 2021-07-14 | 16 |
| ANDA 216848 | LEPU PHARM | 2022-11-03 | 4 |
| ANDA 216436 | BIOCON PHARMA | 2022-11-23 | 10 |
| NDA 213260 | CMP DEV LLC | 2023-02-01 | 1 |
| ANDA 214344 | HETERO LABS LTD V | 2023-09-12 | 45 |
| ANDA 212103 | CADILA PHARMS LTD | 2023-10-16 | 4 |
| ANDA 217081 | MANKIND PHARMA | 2024-01-05 | 20 |
| ANDA 214513 | LAURUS | 2024-01-22 | 5 |
| ANDA 217118 | AUROBINDO PHARMA LTD | 2024-02-13 | 7 |
| ANDA 208480 | MACLEODS PHARMS | 2024-06-03 | 4 |
| ANDA 220276 | TEVA PHARMS INC | 2025-11-13 | 4 |
Official labeling on DailyMed
- ATORVASTATIN CALCIUM TABLET, FILM COATED [APOTEX CORP.] · version 35 · 2026-09-10
- ATORVASTATIN CALCIUM TABLET, FILM COATED [QUALLENT] · version 12 · 2026-09-10
- ATORVASTATIN CALCIUM TABLET [REMEDYREPACK INC.] · version 3 · 2026-09-07
- ATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS] · version 17 · 2026-09-02
- ATORVASTATIN CALCIUM TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] · version 20 · 2026-08-31
- ATORVASTATIN CALCIUM TABLET, FILM COATED [REMEDYREPACK INC.] · version 6 · 2026-08-31
- ATORVASTATIN CALCIUM TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY] · version 3 · 2026-08-28
- ATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH 107, LLC] · version 14 · 2026-08-17
- ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] · version 28 · 2026-08-17
- ATORVASTATIN CALCIUM TABLET, FILM COATED [REMEDYREPACK INC.] · version 9 · 2026-08-07
- ATORVASTATIN CALCIUM TABLET, FILM COATED [REMEDYREPACK INC.] · version 15 · 2026-08-07
- ATORVASTATIN CALCIUM TABLET, FILM COATED [REMEDYREPACK INC.] · version 8 · 2026-08-07
Showing the 12 most recent of 248 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.