FDA Orange Book
Generic for Adcirca
Adcirca 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 Adcirca is tadalafil. 29 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2.
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Adcirca products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 20MG | Marketed (Rx) | AB2 | 39 | AB1, AB2 |
NDA 022332, held by ELI LILLY 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 | 20MG |
| 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 |
| ACCORD HEALTHCARE INC | 209167 | AB1 (A-rated, therapeutically equivalent) | March 26, 2019 | 20MG |
| AJANTA PHARMA LTD | 209654 | AB1 (A-rated, therapeutically equivalent) | March 26, 2019 | 20MG |
| ALEMBIC PHARMACEUTICALS LTD | 204809 | AB1 (A-rated, therapeutically equivalent) | March 26, 2019 | 20MG |
| AMNEAL PHARMACEUTICALS CO GMBH | 209744 | AB1 (A-rated, therapeutically equivalent) | March 26, 2019 | 20MG |
| AUROBINDO PHARMA LTD | 206285 | AB1 (A-rated, therapeutically equivalent) | March 26, 2019 | 20MG |
| CIPLA LTD | 209539 | AB1 (A-rated, therapeutically equivalent) | March 26, 2019 | 20MG |
| DR REDDYS LABORATORIES LTD | 210069 | AB1 (A-rated, therapeutically equivalent) | March 26, 2019 | 20MG |
| HETERO LABS LTD UNIT III | 209908 | AB1 (A-rated, therapeutically equivalent) | March 26, 2019 | 20MG |
| LUPIN LTD | 210567 | AB1 (A-rated, therapeutically equivalent) | March 26, 2019 | 20MG |
| QILU PHARMACEUTICAL HAINAN CO LTD | 210420 | AB1 (A-rated, therapeutically equivalent) | March 26, 2019 | 20MG |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 208934 | AB1 (A-rated, therapeutically equivalent) | March 26, 2019 | 20MG |
| SUNSHINE LAKE PHARMA CO LTD | 211335 | AB1 (A-rated, therapeutically equivalent) | March 26, 2019 | 20MG |
| TORRENT PHARMACEUTICALS LTD | 211839 | AB1 (A-rated, therapeutically equivalent) | March 26, 2019 | 20MG |
| TORRENT PHARMACEUTICALS LTD | 212062 | AB2 (A-rated, therapeutically equivalent) | March 26, 2019 | 20MG |
| UNICHEM LABORATORIES LTD | 209250 | AB1 (A-rated, therapeutically equivalent) | March 26, 2019 | 20MG |
| ZYDUS PHARMACEUTICALS USA INC | 206693 | AB1 (A-rated, therapeutically equivalent) | March 26, 2019 | 20MG |
| WATSON LABORATORIES INC | 205885 | AB1 (A-rated, therapeutically equivalent) | March 29, 2019 | 20MG |
Adcirca NDC codes
Questions
Is there a generic for Adcirca?
Yes. The generic name for Adcirca 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 Adcirca?
The active ingredient in Adcirca 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.