Active ingredient
Silodosin
29 finished FDA listings contain Silodosin as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- SILODOSIN
- Dosage forms
- Capsule
- Routes
- Oral
- Manufacturers / labelers
- 13
- Strengths listed
- 4 mg/1 · 8 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 720825
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 |
|---|---|---|---|
| ANDA 209745 | AMNEAL PHARMS CO | 2018-12-03 | 6 |
| ANDA 210687 | MSN | 2018-12-03 | 3 |
| ANDA 211166 | MACLEODS PHARMS | 2018-12-03 | 3 |
| ANDA 206541 | LUPIN | 2018-12-03 | 2 |
| ANDA 211060 | AJANTA PHARMA LTD | 2018-12-03 | 2 |
| ANDA 210626 | AUROBINDO PHARMA LTD | 2018-12-10 | 3 |
| ANDA 211731 | ALEMBIC | 2019-11-22 | 4 |
| ANDA 204793 | HETERO LABS LTD V | 2020-02-14 | 2 |
| ANDA 213230 | PHARMAZONE | 2022-01-03 | 4 |
Official labeling on DailyMed
- SILODOSIN CAPSULE [NOVADOZ PHARMACEUTICALS LLC] · version 3 · 2026-09-01
- SILODOSIN CAPSULE [BRYANT RANCH PREPACK] · version 2 · 2026-07-09
- SILODOSIN CAPSULE [CREEKWOOD PHARMACEUTICALS LLC] · version 4 · 2026-05-11
- SILODOSIN CAPSULE [AMNEAL PHARMACEUTICALS NY LLC] · version 8 · 2026-04-27
- SILODOSIN CAPSULE [BRYANT RANCH PREPACK] · version 101 · 2026-03-18
- SILODOSIN CAPSULE [BRYANT RANCH PREPACK] · version 101 · 2026-03-18
- SILODOSIN CAPSULE [AVKARE] · version 3 · 2026-01-16
- SILODOSIN CAPSULE [AJANTA PHARMA USA INC.] · version 6 · 2025-12-12
- SILODOSIN CAPSULE [LUPIN PHARMACEUTICALS, INC.] · version 11 · 2025-11-17
- SILODOSIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] · version 8 · 2025-11-17
- SILODOSIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] · version 8 · 2025-10-06
- SILODOSIN (SILODOSIN) CAPSULE [CAMBER PHARMACEUTICALS, INC.] · version 2 · 2024-06-06
Showing the 12 most recent of 17 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.