FDA Orange Book
Generic for Cialis
Cialis contains tadalafil. 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 Cialis is tadalafil. 29 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2.
Run it in Rivvi
Map Cialis and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Cialis products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG | Marketed (Rx) | AB1 | 26 | AB1 |
| tablet, oral | 2.5MG | Discontinued | None | 25 | AB1 |
| tablet, oral | 20MG | Marketed (Rx) | AB1 | 39 | AB1, AB2 |
| tablet, oral | 5MG | Marketed (Rx) | AB1 | 26 | AB1 |
NDA 021368, held by ELI LILLY AND CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic tadalafil
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA | 090141 | AB1 (A-rated, therapeutically equivalent) | May 22, 2018 | 10MG, 2.5MG, 20MG, 5MG |
| TEVA PHARMACEUTICALS USA INC | 209942 | AB2 (A-rated, therapeutically equivalent) | February 5, 2019 | 20MG |
| AJANTA PHARMA LTD | 210392 | AB2 (A-rated, therapeutically equivalent) | February 5, 2019 | 20MG |
| AUROBINDO PHARMA LTD | 206286 | AB2 (A-rated, therapeutically equivalent) | February 5, 2019 | 20MG |
| CHARTWELL RX SCIENCES LLC | 210572 | AB2 (A-rated, therapeutically equivalent) | February 5, 2019 | 20MG |
| CIPLA LTD | 210255 | AB2 (A-rated, therapeutically equivalent) | February 5, 2019 | 20MG |
| DR REDDYS LABORATORIES LTD | 210145 | AB2 (A-rated, therapeutically equivalent) | February 5, 2019 | 20MG |
| HETERO LABS LTD UNIT III | 209907 | AB2 (A-rated, therapeutically equivalent) | February 5, 2019 | 20MG |
| AJANTA PHARMA LTD | 209654 | AB1 (A-rated, therapeutically equivalent) | March 26, 2019 | 10MG, 2.5MG, 20MG, 5MG |
| ALEMBIC PHARMACEUTICALS LTD | 204809 | AB1 (A-rated, therapeutically equivalent) | March 26, 2019 | 10MG, 2.5MG, 20MG, 5MG |
| AMNEAL PHARMACEUTICALS CO GMBH | 209744 | AB1 (A-rated, therapeutically equivalent) | March 26, 2019 | 10MG, 2.5MG, 20MG, 5MG |
| AUROBINDO PHARMA LTD | 206285 | AB1 (A-rated, therapeutically equivalent) | March 26, 2019 | 10MG, 2.5MG, 20MG, 5MG |
| CIPLA LTD | 209539 | AB1 (A-rated, therapeutically equivalent) | March 26, 2019 | 10MG, 2.5MG, 20MG, 5MG |
| DR REDDYS LABORATORIES LTD | 210069 | AB1 (A-rated, therapeutically equivalent) | March 26, 2019 | 10MG, 2.5MG, 20MG, 5MG |
| HETERO LABS LTD UNIT III | 209908 | AB1 (A-rated, therapeutically equivalent) | March 26, 2019 | 10MG, 2.5MG, 20MG, 5MG |
| LUPIN LTD | 210567 | AB1 (A-rated, therapeutically equivalent) | March 26, 2019 | 10MG, 2.5MG, 20MG, 5MG |
| QILU PHARMACEUTICAL HAINAN CO LTD | 210420 | AB1 (A-rated, therapeutically equivalent) | March 26, 2019 | 10MG, 2.5MG, 20MG, 5MG |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 208934 | AB1 (A-rated, therapeutically equivalent) | March 26, 2019 | 10MG, 2.5MG, 20MG, 5MG |
| SUNSHINE LAKE PHARMA CO LTD | 211335 | AB1 (A-rated, therapeutically equivalent) | March 26, 2019 | 10MG, 2.5MG, 20MG, 5MG |
| TORRENT PHARMACEUTICALS LTD | 211839 | AB1 (A-rated, therapeutically equivalent) | March 26, 2019 | 10MG, 2.5MG, 20MG, 5MG |
| UNICHEM LABORATORIES LTD | 209250 | AB1 (A-rated, therapeutically equivalent) | March 26, 2019 | 10MG, 2.5MG, 20MG, 5MG |
| ZYDUS PHARMACEUTICALS USA INC | 206693 | AB1 (A-rated, therapeutically equivalent) | March 26, 2019 | 10MG, 2.5MG, 20MG, 5MG |
| TORRENT PHARMACEUTICALS LTD | 212062 | AB2 (A-rated, therapeutically equivalent) | March 26, 2019 | 20MG |
| WATSON LABORATORIES INC | 205885 | AB1 (A-rated, therapeutically equivalent) | March 29, 2019 | 10MG, 2.5MG, 20MG, 5MG |
| MACLEODS PHARMACEUTICALS LTD | 207244 | AB1 (A-rated, therapeutically equivalent) | October 7, 2019 | 10MG, 2.5MG, 5MG |
| ACCORD HEALTHCARE INC | 209167 | AB1 (A-rated, therapeutically equivalent) | October 23, 2019 | 10MG, 2.5MG, 20MG, 5MG |
| UMEDICA LABORATORIES PRIVATE LTD | 211298 | AB1 (A-rated, therapeutically equivalent) | October 23, 2020 | 10MG, 2.5MG, 5MG |
| HANGZHOU MINSHENG BINJIANG PHARMACEUTICAL CO LTD | 208824 | AB1 (A-rated, therapeutically equivalent) | October 27, 2020 | 10MG, 2.5MG, 5MG |
| VKT PHARMA PRIVATE LTD | 215556 | AB1 (A-rated, therapeutically equivalent) | November 4, 2021 | 10MG, 2.5MG, 5MG |
| PRINSTON PHARMACEUTICAL INC | 210609 | AB1 (A-rated, therapeutically equivalent) | August 11, 2022 | 10MG, 2.5MG, 5MG |
| NOVITIUM PHARMA LLC | 215949 | AB1 (A-rated, therapeutically equivalent) | March 3, 2023 | 10MG, 5MG |
| RISING PHARMA HOLDINGS INC | 217606 | AB1 (A-rated, therapeutically equivalent) | August 13, 2024 | 10MG, 2.5MG, 5MG |
| SHANDONG NEW TIME PHARMACEUTICAL CO LTD | 216279 | AB1 (A-rated, therapeutically equivalent) | December 4, 2024 | 10MG, 2.5MG, 5MG |
| JUBILANT GENERICS LTD | 210329 | AB1 (A-rated, therapeutically equivalent) | May 15, 2026 | 2.5MG |
Cialis NDC codes
Questions
Is there a generic for Cialis?
Yes. The generic name for Cialis is tadalafil. 29 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2.
What is the generic name for Cialis?
The active ingredient in Cialis is tadalafil, 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.