Active ingredient
Levothyroxine
601 finished FDA listings contain Levothyroxine as their only active ingredient; 69 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- LEVOTHYROXINE, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS
- Dosage forms
- Capsule, Injection, Injection, Powder, Lyophilized, For Solution, Injection, Solution, Liquid, Solution, Tablet
- Routes
- Intravenous, Oral
- Manufacturers / labelers
- 55
- Strengths listed
- .025 mg/1 · .05 mg/1 · .075 mg/1 · .088 mg/1 · .1 mg/1 · .112 mg/1 · .125 mg/1 · .137 mg/1 · .15 mg/1 · .175 mg/1 · .2 mg/1 · .3 mg/1 · 100 ug/1 · 100 ug/5ml · 100 ug/ml · 112 ug/1 · 112 ug/ml · 12 [hp_x]/ml · 125 ug/1 · 125 ug/ml · 13 ug/1 · 13 ug/ml · 137 ug/1 · 137 ug/ml · 150 ug/1 · 150 ug/ml · 175 ug/1 · 175 ug/ml · 20 ug/ml · 200 ug/1 · 200 ug/5ml · 200 ug/ml · 25 ug/1 · 25 ug/ml · 300 ug/1 · 37.5 ug/1 · 37.5 ug/ml · 40 ug/ml · 44 ug/1 · 44 ug/ml · 50 ug/1 · 50 ug/ml · 500 ug/5ml · 62.5 ug/1 · 62.5 ug/ml · 75 ug/1 · 75 ug/ml · 88 ug/1 · 88 ug/ml
- Brand names in FDA listings
- Euthyrox, Levothyroxine Sodium, Levoxyl, Synthroid, Thyquidity, Thyroxine Cord, Tirosint, Tirosint Sol, Unithroid
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 10582
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 021210 | STEVENS J | 2000-08-21 | 48 |
| NDA 021301 | KING PHARMS | 2001-05-25 | 11 |
| NDA 021342 | CEDIPROF INC | 2002-03-01 | 59 |
| NDA 021292 | EMD SERONO INC | 2002-05-31 | 5 |
| ANDA 076187 | MYLAN | 2002-06-05 | 30 |
| NDA 021402 | ABBVIE | 2002-07-24 | 12 |
| NDA 021116 | ALVOGEN | 2002-10-24 | 65 |
| NDA 021924 | IBSA | 2006-10-13 | 27 |
| NDA 202231 | FRESENIUS KABI USA | 2011-06-24 | 9 |
| ANDA 206163 | PIRAMAL CRITICAL | 2016-06-29 | 2 |
| NDA 206977 | IBSA | 2016-12-15 | 15 |
| ANDA 208749 | MAIA PHARMS INC | 2018-12-21 | 6 |
| ANDA 209713 | LUPIN | 2019-01-18 | 100 |
| NDA 210632 | FRESENIUS KABI USA | 2019-04-11 | 5 |
| ANDA 212399 | ACCORD HLTHCARE | 2020-10-19 | 93 |
| NDA 214047 | STEVENS J | 2020-11-30 | 1 |
| NDA 214253 | HIKMA | 2021-05-17 | 1 |
| ANDA 207588 | WATSON LABS TEVA | 2022-05-10 | 16 |
| ANDA 211417 | MACLEODS PHARMS | 2022-12-21 | 58 |
| ANDA 215259 | ASCENT PHARMS INC | 2023-01-18 | 24 |
| ANDA 217066 | ZYDUS PHARMS | 2023-03-24 | 4 |
| ANDA 216414 | AUROBINDO PHARMA | 2024-07-16 | 5 |
| ANDA 216729 | ONESOURCE SPECIALTY | 2025-03-05 | 4 |
Official labeling on DailyMed
- LEVOTHYROXINE SODIUM TABLET [REMEDYREPACK INC.] · version 3 · 2026-09-11
- LEVOTHYROXINE SODIUM TABLET [REMEDYREPACK INC.] · version 3 · 2026-09-11
- LEVOTHYROXINE SODIUM TABLET [REMEDYREPACK INC.] · version 3 · 2026-09-11
- LEVOTHYROXINE SODIUM TABLET [REMEDYREPACK INC.] · version 3 · 2026-09-11
- LEVOTHYROXINE SODIUM TABLET [REMEDYREPACK INC.] · version 3 · 2026-09-11
- LEVOTHYROXINE SODIUM TABLET [REMEDYREPACK INC.] · version 3 · 2026-09-10
- LEVOTHYROXINE SODIUM TABLET [NUCARE PHARMACEUTICALS, INC.] · version 1 · 2026-08-26
- LEVOTHYROXINE SODIUM TABLET [NORTHSTAR RXLLC] · version 4 · 2026-08-21
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM ANHYDROUS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ONESOURCE SPECIALTY PHARMA LIMITED] · version 4 · 2026-08-13
- LEVOTHYROXINE SODIUM TABLET [COUPLER LLC] · version 1 · 2026-07-07
- LEVOTHYROXINE SODIUM TABLET [COUPLER LLC] · version 1 · 2026-07-07
- LEVOTHYROXINE SODIUM TABLET [BRYANT RANCH PREPACK] · version 102 · 2026-06-25
Showing the 12 most recent of 282 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.