Active ingredient
Mycophenolate
39 finished FDA listings contain Mycophenolate as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- MYCOPHENOLATE SODIUM
- Dosage forms
- Tablet, Delayed Release
- Routes
- Oral
- Manufacturers / labelers
- 18
- Strengths listed
- 180 mg/1 · 360 mg/1
- Brand names in FDA listings
- Myfortic
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 265323
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 050791 | NOVARTIS | 2004-02-27 | 2 |
| ANDA 091558 | APOTEX INC | 2012-08-21 | 8 |
| ANDA 202555 | ACCORD HLTHCARE | 2017-08-23 | 2 |
| ANDA 211173 | CONCORD BIOTECH LTD | 2019-12-13 | 6 |
| ANDA 214376 | YICHANG HUMANWELL | 2021-02-10 | 2 |
| ANDA 208315 | ALKEM LABS LTD | 2021-09-23 | 7 |
| ANDA 214289 | TWI PHARMS | 2021-11-03 | 4 |
| ANDA 214630 | BIOCON PHARMA | 2021-11-29 | 2 |
| ANDA 217031 | BIOCON PHARMA | 2023-11-29 | 2 |
| ANDA 218603 | AUROBINDO PHARMA LTD | 2024-02-27 | 2 |
| ANDA 216637 | FOSUN WANBANG | 2024-05-29 | 2 |
Official labeling on DailyMed
- MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [STELLON BIOTECH INC.] · version 1 · 2026-09-11
- MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [REMEDYREPACK INC.] · version 3 · 2026-09-10
- MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [APOTEX CORP] · version 26 · 2026-09-03
- MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [BIOCON PHARMA INC.] · version 2 · 2026-08-21
- MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [BIOCON PHARMA INC.] · version 10 · 2026-08-21
- MYFORTIC (MYCOPHENOLIC ACID) TABLET, DELAYED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION] · version 36 · 2026-08-11
- MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING] · version 10 · 2026-07-30
- MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS] · version 3 · 2026-07-20
- MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.] · version 13 · 2026-07-13
- MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS] · version 6 · 2026-06-30
- MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [SLATE RUN PHARMACEUTICALS, LLC] · version 13 · 2026-06-01
- MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [ASCEND LABORATORIES, LLC] · version 1 · 2026-04-22
Showing the 12 most recent of 19 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.