Active ingredient
Mycophenolate Mofetil
63 finished FDA listings contain Mycophenolate Mofetil as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE
- Dosage forms
- Capsule, Injection, Powder, Lyophilized, For Solution, Powder, For Suspension, Suspension, Tablet, Tablet, Film Coated
- Routes
- Intravenous, Oral
- Manufacturers / labelers
- 38
- Strengths listed
- 200 mg/ml · 250 mg/1 · 500 mg/1 · 500 mg/20ml
- Brand names in FDA listings
- Cellcept, Mycophenolate Mofetil, Myhibbin
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 68149
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 050722 | ROCHE PALO | 1995-05-03 | 1 |
| NDA 050723 | ROCHE PALO | 1997-06-19 | 1 |
| NDA 050758 | ROCHE PALO | 1998-08-12 | 1 |
| NDA 050759 | ROCHE PALO | 1998-10-01 | 1 |
| ANDA 065413 | HIKMA | 2008-07-29 | 1 |
| ANDA 065451 | SANDOZ | 2008-10-15 | 1 |
| ANDA 065379 | SANDOZ | 2008-10-15 | 1 |
| ANDA 065521 | MYLAN | 2009-05-04 | 1 |
| ANDA 065416 | ACCORD HLTHCARE | 2009-05-04 | 2 |
| ANDA 090253 | ACCORD HLTHCARE | 2009-05-04 | 1 |
| ANDA 065491 | TEVA PHARMS | 2009-05-06 | 1 |
| ANDA 090456 | STRIDES PHARMA | 2010-06-10 | 11 |
| ANDA 090055 | STRIDES PHARMA | 2010-06-10 | 5 |
| ANDA 091249 | ALKEM LABS LTD | 2011-11-04 | 3 |
| ANDA 200197 | ALKEM LABS LTD | 2013-06-13 | 5 |
| ANDA 203005 | ALKEM LABS LTD | 2014-11-14 | 1 |
| ANDA 203575 | PH HEALTH | 2016-10-28 | 1 |
| ANDA 203859 | MYLAN LABS LTD | 2017-03-31 | 1 |
| ANDA 210181 | CONCORD BIOTECH LTD | 2019-01-08 | 3 |
| ANDA 210370 | VISTAPHARM LLC | 2019-02-12 | 1 |
| ANDA 212087 | CONCORD BIOTECH LTD | 2020-07-31 | 2 |
| ANDA 212130 | MEITHEAL | 2021-01-15 | 1 |
| ANDA 214525 | QUAGEN | 2021-07-29 | 2 |
| ANDA 214871 | AMNEAL | 2021-11-02 | 2 |
| ANDA 216390 | ONESOURCE SPECIALTY | 2022-12-23 | 2 |
| ANDA 214283 | BPI LABS | 2023-06-01 | 1 |
| ANDA 212634 | STRIDES PHARMA INTL | 2023-08-29 | 2 |
| ANDA 217828 | AUROBINDO PHARMA LTD | 2024-01-05 | 1 |
| ANDA 217937 | AUROBINDO PHARMA | 2024-02-20 | 1 |
| NDA 216482 | AZURITY | 2024-05-01 | 1 |
| ANDA 218227 | AUROBINDO PHARMA LTD | 2024-09-26 | 2 |
| ANDA 208119 | HETERO LABS LTD V | 2024-10-22 | 1 |
| ANDA 207022 | HETERO LABS LTD V | 2024-10-22 | 1 |
| ANDA 214079 | WUXI | 2024-11-07 | 1 |
Official labeling on DailyMed
- MYCOPHENOLATE MOFETIL TABLET, FILM COATED [REMEDYREPACK INC.] · version 3 · 2026-09-10
- MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [STRIDES PHARMA INC.] · version 3 · 2026-09-09
- MYCOPHENOLATE MOFETIL CAPSULE [TEVA PHARMACEUTICALS USA, INC.] · version 34 · 2026-09-08
- MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION [STRIDES PHARMA SCIENCE LIMITED] · version 12 · 2026-09-02
- MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [AVPAK] · version 3 · 2026-08-27
- MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION [AMNEAL PHARMACEUTICALS LLC] · version 17 · 2026-08-21
- MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION [QUAGEN PHARMACEUTICALS LLC] · version 1 · 2026-08-17
- MYCOPHENOLATE MOFETIL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] · version 15 · 2026-08-11
- CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.] · version 51 · 2026-08-10
- MYCOPHENOLATE MOFETIL CAPSULE [MAJOR PHARMACEUTICALS] · version 3 · 2026-07-28
- MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [HIKMA PHARMACEUTICALS USA INC.] · version 22 · 2026-07-06
- MYCOPHENOLATE MOFETIL CAPSULE [REMEDYREPACK INC.] · version 5 · 2026-06-15
Showing the 12 most recent of 43 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.