Active ingredient
Colchicine
49 finished FDA listings contain Colchicine as their only active ingredient; 4 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- COLCHICINE
- Dosage forms
- Capsule, Solution, Tablet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 32
- Strengths listed
- .5 mg/1 · .6 mg/1 · .6 mg/5ml
- Brand names in FDA listings
- Colcrys, Gloperba, Lodoco, Mitigare
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2683
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 022352 | TAKEDA PHARMS USA | 2009-07-29 | 5 |
| NDA 204820 | HIKMA INTL PHARMS | 2014-09-26 | 6 |
| ANDA 204711 | AMNEAL PHARMS | 2016-09-28 | 2 |
| ANDA 208678 | PH HEALTH | 2018-11-29 | 1 |
| NDA 210942 | SCILEX PHARMS | 2019-01-30 | 1 |
| ANDA 211250 | ALKEM LABS LTD | 2019-02-08 | 7 |
| ANDA 209876 | DR REDDYS | 2019-09-06 | 5 |
| ANDA 209470 | MYLAN | 2019-09-16 | 1 |
| ANDA 210425 | GRANULES | 2020-02-05 | 5 |
| ANDA 203976 | PH HEALTH | 2021-08-12 | 2 |
| ANDA 208993 | HETERO LABS LTD V | 2021-08-13 | 4 |
| ANDA 215444 | AUROBINDO PHARMA LTD | 2022-01-06 | 1 |
| ANDA 209173 | STRIDES PHARMA | 2022-03-10 | 1 |
| NDA 215727 | AGEPHA PHARMA FZ | 2023-06-16 | 1 |
| ANDA 217620 | ANNORA PHARMA | 2024-04-29 | 2 |
| ANDA 215463 | AUROBINDO PHARMA LTD | 2024-04-29 | 2 |
| ANDA 210757 | GRANULES | 2024-04-29 | 1 |
| ANDA 210633 | MACLEODS PHARMS | 2026-02-13 | 1 |
| ANDA 212880 | MICRO LABS | 2026-02-17 | 1 |
Official labeling on DailyMed
- COLCHICINE TABLET, FILM COATED [DIRECT_RX] · version 1 · 2026-08-31
- COLCHICINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] · version 8 · 2026-08-25
- LODOCO (COLCHICINE TABLETS 0.5 MG) TABLET [AGEPHA PHARMA USA, LLC] · version 4 · 2026-08-17
- COLCHICINE TABLET [A-S MEDICATION SOLUTIONS] · version 1 · 2026-07-16
- COLCHICINE TABLET [BRYANT RANCH PREPACK] · version 107 · 2026-07-15
- COLCHICINE CAPSULE [PAR HEALTH USA, LLC] · version 25 · 2026-06-26
- COLCHICINE TABLET, FILM COATED [PAR HEALTH USA, LLC] · version 11 · 2026-06-26
- COLCHICINE TABLET [ASCEND LABORATORIES, LLC] · version 10 · 2026-06-26
- COLCHICINE TABLET, FILM COATED [REMEDYREPACK INC.] · version 7 · 2026-06-23
- COLCHICINE TABLET [REMEDYREPACK INC.] · version 4 · 2026-06-15
- COLCHICINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] · version 2 · 2026-05-22
- COLCHICINE TABLET [DR.REDDYS LABORATORIES, INC.] · version 11 · 2026-05-20
Showing the 12 most recent of 49 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.