Active ingredient
Tadalafil
252 finished FDA listings contain Tadalafil as their only active ingredient; 2 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- TADALAFIL
- Dosage forms
- Suspension, Tablet, Tablet, Coated, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 53
- Strengths listed
- 10 mg/1 · 2.5 mg/1 · 20 mg/1 · 20 mg/5ml · 5 mg/1
- Brand names in FDA listings
- Adcirca, Alyq, Cialis, Tadliq
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 358263
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 021368 | LILLY | 2003-11-21 | 3 |
| NDA 022332 | ELI LILLY CO | 2009-05-22 | 1 |
| ANDA 206286 | AUROBINDO PHARMA LTD | 2019-02-05 | 2 |
| ANDA 210255 | CIPLA | 2019-02-05 | 1 |
| ANDA 210572 | CHARTWELL RX | 2019-02-05 | 1 |
| ANDA 210392 | AJANTA PHARMA LTD | 2019-02-05 | 2 |
| ANDA 209907 | HETERO LABS LTD III | 2019-02-05 | 1 |
| ANDA 210145 | DR REDDYS | 2019-02-05 | 1 |
| ANDA 204809 | ALEMBIC | 2019-03-26 | 8 |
| ANDA 211839 | TORRENT | 2019-03-26 | 7 |
| ANDA 206285 | AUROBINDO PHARMA LTD | 2019-03-26 | 4 |
| ANDA 210069 | DR REDDYS | 2019-03-26 | 4 |
| ANDA 211335 | SUNSHINE | 2019-03-26 | 4 |
| ANDA 209654 | AJANTA PHARMA LTD | 2019-03-26 | 31 |
| ANDA 209167 | ACCORD HLTHCARE | 2019-03-26 | 19 |
| ANDA 209250 | UNICHEM | 2019-03-26 | 18 |
| ANDA 208934 | SUN PHARM | 2019-03-26 | 18 |
| ANDA 209744 | AMNEAL PHARMS CO | 2019-03-26 | 15 |
| ANDA 209908 | HETERO LABS LTD III | 2019-03-26 | 12 |
| ANDA 206693 | ZYDUS PHARMS | 2019-03-26 | 9 |
| ANDA 210420 | QILU PHARM HAINAN | 2019-03-26 | 9 |
| ANDA 212062 | TORRENT | 2019-03-26 | 1 |
| ANDA 205885 | WATSON LABS INC | 2019-03-29 | 2 |
| ANDA 207244 | MACLEODS PHARMS | 2019-10-07 | 6 |
| ANDA 207290 | MACLEODS PHARMS | 2019-10-16 | 1 |
| ANDA 211298 | UMEDICA | 2020-10-23 | 18 |
| ANDA 208824 | HANGZHOU BINJIANG | 2020-10-27 | 4 |
| ANDA 215556 | VKT PHARMA | 2021-11-04 | 13 |
| NDA 214522 | CMP DEV LLC | 2022-06-17 | 1 |
| ANDA 210608 | PRINSTON INC | 2022-08-11 | 3 |
| ANDA 210609 | PRINSTON INC | 2022-08-11 | 24 |
| ANDA 216932 | TEVA PHARMS INC | 2022-10-12 | 1 |
| ANDA 215949 | NOVITIUM PHARMA | 2023-03-03 | 3 |
| ANDA 217606 | RISING | 2024-08-13 | 4 |
Official labeling on DailyMed
- TADALAFIL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] · version 1 · 2026-09-10
- TADALAFIL TABLET [A-S MEDICATION SOLUTIONS] · version 9 · 2026-09-10
- TADALAFIL TABLET, FILM COATED [TEVA PHARMACEUTICALS, INC.] · version 9 · 2026-09-02
- TADALAFIL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] · version 2 · 2026-08-31
- TADALAFIL TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] · version 4 · 2026-08-31
- TADALAFIL TABLET [NUCARE PHARMACEUTICALS, INC.] · version 3 · 2026-08-31
- TADALAFIL TABLET [NUCARE PHARMACEUTICALS,INC.] · version 6 · 2026-08-31
- TADALAFIL TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 1 · 2026-08-31
- TADALAFIL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] · version 7 · 2026-08-26
- ALYQ (TADALAFIL) TABLET, FILM COATED [TEVA PHARMACEUTICALS, INC.] · version 6 · 2026-08-20
- TADALAFIL TABLET [NUCARE PHARMACEUTICALS,INC.] · version 2 · 2026-08-19
- TADALAFIL TABLET, FILM COATED [NORTHSTAR RX, LLC] · version 1 · 2026-08-03
Showing the 12 most recent of 140 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.