FDA Orange Book
Generic for CellCept
CellCept contains mycophenolate mofetil. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for CellCept is mycophenolate mofetil. 23 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
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CellCept products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 250MG | Marketed (Rx) | AB | 10 | AB |
| for suspension, oral | 200MG/ML | Marketed (Rx) | AB | 8 | AB |
| injectable, injection | 500MG/VIAL | Marketed (Rx) | AP | 7 | AP |
| tablet, oral | 500MG | Marketed (Rx) | AB | 8 | AB |
NDA 050722, 050759, 050758, 050723, held by ROCHE PALO ALTO LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic mycophenolate mofetil
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SANDOZ INC | 065379 | AB (A-rated, therapeutically equivalent) | October 15, 2008 | 250MG |
| SANDOZ INC | 065451 | AB (A-rated, therapeutically equivalent) | October 15, 2008 | 500MG |
| ACCORD HEALTHCARE INC | 090253 | AB (A-rated, therapeutically equivalent) | May 4, 2009 | 250MG |
| ACCORD HEALTHCARE INC | 065416 | AB (A-rated, therapeutically equivalent) | May 4, 2009 | 500MG |
| TEVA PHARMACEUTICALS USA | 065491 | AB (A-rated, therapeutically equivalent) | May 6, 2009 | 250MG |
| STRIDES PHARMA GLOBAL PTE LTD | 090055 | AB (A-rated, therapeutically equivalent) | June 10, 2010 | 250MG |
| STRIDES PHARMA GLOBAL PTE LTD | 090456 | AB (A-rated, therapeutically equivalent) | June 10, 2010 | 500MG |
| ALKEM LABORATORIES LTD | 091249 | AB (A-rated, therapeutically equivalent) | November 4, 2011 | 500MG |
| ALKEM LABORATORIES LTD | 200197 | AB (A-rated, therapeutically equivalent) | June 13, 2013 | 250MG |
| ALKEM LABORATORIES LTD | 203005 | AB (A-rated, therapeutically equivalent) | November 14, 2014 | 200MG/ML |
| PH HEALTH LTD | 203575 | AP (A-rated, therapeutically equivalent) | October 28, 2016 | 500MG/VIAL |
| RISING PHARMA HOLDINGS INC | 204043 | AP (A-rated, therapeutically equivalent) | February 28, 2017 | 500MG/VIAL |
| MYLAN LABORATORIES LTD | 203859 | AP (A-rated, therapeutically equivalent) | March 31, 2017 | 500MG/VIAL |
| ZYDUS PHARMACEUTICALS USA INC | 204473 | AP (A-rated, therapeutically equivalent) | August 31, 2017 | 500MG/VIAL |
| ZHEJIANG HISUN PHARMACEUTICAL CO LTD | 204077 | AB (A-rated, therapeutically equivalent) | November 13, 2017 | 250MG |
| ZHEJIANG HISUN PHARMACEUTICAL CO LTD | 204076 | AB (A-rated, therapeutically equivalent) | November 16, 2017 | 500MG |
| CONCORD BIOTECH LTD | 210181 | AB (A-rated, therapeutically equivalent) | January 8, 2019 | 250MG |
| VISTAPHARM LLC | 210370 | AB (A-rated, therapeutically equivalent) | February 12, 2019 | 200MG/ML |
| CONCORD BIOTECH LTD | 212087 | AB (A-rated, therapeutically equivalent) | July 31, 2020 | 500MG |
| MEITHEAL PHARMACEUTICALS INC | 212130 | AP (A-rated, therapeutically equivalent) | January 15, 2021 | 500MG/VIAL |
| QUAGEN PHARMACEUTICALS LLC | 214525 | AB (A-rated, therapeutically equivalent) | July 29, 2021 | 200MG/ML |
| AMNEAL PHARMACEUTICALS LLC | 214871 | AB (A-rated, therapeutically equivalent) | November 2, 2021 | 200MG/ML |
| ONESOURCE SPECIALTY PTE LTD | 216390 | AP (A-rated, therapeutically equivalent) | December 23, 2022 | 500MG/VIAL |
| BPI LABS LLC | 214283 | AP (A-rated, therapeutically equivalent) | June 1, 2023 | 500MG/VIAL |
| STRIDES PHARMA INTERNATIONAL AG | 212634 | AB (A-rated, therapeutically equivalent) | August 29, 2023 | 200MG/ML |
| RISING PHARMA HOLDING INC | 213955 | AB (A-rated, therapeutically equivalent) | September 11, 2023 | 200MG/ML |
| AUROBINDO PHARMA LTD | 217828 | AB (A-rated, therapeutically equivalent) | January 5, 2024 | 250MG |
| AUROBINDO PHARMA LTD | 217937 | AB (A-rated, therapeutically equivalent) | February 20, 2024 | 500MG |
| AUROBINDO PHARMA LTD | 218227 | AB (A-rated, therapeutically equivalent) | September 26, 2024 | 200MG/ML |
| HETERO LABS LTD UNIT V | 207022 | AB (A-rated, therapeutically equivalent) | October 22, 2024 | 250MG |
| HETERO LABS LTD UNIT V | 208119 | AB (A-rated, therapeutically equivalent) | October 22, 2024 | 500MG |
| WUXI FORTUNE PHARMACEUTICAL CO LTD | 214079 | AB (A-rated, therapeutically equivalent) | November 7, 2024 | 250MG |
| NEOCUBES PHARMA LLP | 218566 | AB (A-rated, therapeutically equivalent) | June 1, 2026 | 200MG/ML |
CellCept NDC codes
Questions
Is there a generic for CellCept?
Yes. The generic name for CellCept is mycophenolate mofetil. 23 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
What is the generic name for CellCept?
The active ingredient in CellCept is mycophenolate mofetil, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.
More on CellCept and Mycophenolate Mofetil
- What is Mycophenolate Mofetil used for?FDA label uses
- Is Mycophenolate Mofetil a controlled substance?Federal schedule
- Generic for MyhibbinFDA Orange Book
- Antimetabolite Immunosuppressants listFDA drug class
- NDC 0004-0259CellCept NDC record
- NDC 0004-0260CellCept NDC record
- NDC 0004-0261CellCept NDC record