Drug
Who makes levothyroxine sodium?
43 companies list levothyroxine sodium as a human prescription drug, including under the names EUTHYROX, LEVOXYL, Synthroid, THYQUIDITY, Tirosint, Tirosint SOL, Unithroid. Forms: capsule; injection; injection, powder, lyophilized, for solution; injection, solution; solution; tablet. Routes: intravenous, oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing levothyroxine sodium
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| International Medication Systems, Ltd.United States | tablet | ANDA, NDA, NDA AUTHORIZED GENERICANDA207588, ANDA209713, ANDA211417 | 74 | 3 |
| Bryant Ranch PrepackUnited States | tablet | ANDA, NDA, NDA AUTHORIZED GENERICANDA207588, ANDA209713, ANDA212399 | 61 | 1 |
| Northwind Health Company, LLCUnited States | tablet | ANDA, NDA, NDA AUTHORIZED GENERICANDA076187, ANDA209713, ANDA212399 | 36 | 1 |
| IBSA Pharma Inc. | capsule; solution | NDANDA021924, NDA206977 | 30 | 0 |
| Preferred Pharmaceuticals Inc.United States | tablet | ANDA, NDAANDA207588, ANDA209713, ANDA211417 | 28 | 1 |
| Proficient Rx LPUnited States | tablet | ANDA, NDA, NDA AUTHORIZED GENERICANDA207588, ANDA209713, ANDA212399 | 28 | 1 |
| NuCare Pharmaceuticals,Inc.United States | tablet | ANDA, NDA, NDA AUTHORIZED GENERICANDA209713, ANDA211417, ANDA212399 | 14 | 1 |
| Alvogen, Inc. | tablet | NDANDA021116 | 14 | 0 |
| Cardinal Health 418, Inc.United States | tablet | ANDAANDA076187, ANDA209713 | 13 | 34 |
| Coupler LLCUnited States | tablet | ANDA, NDA AUTHORIZED GENERICANDA209713, ANDA211417, NDA021342 | 13 | 1 |
| Direct RxUnited States | tablet | ANDA, NDAANDA209713, ANDA212399, NDA021116 | 13 | 1 |
| RemedyRepack, IncUnited States | tablet | ANDAANDA209713, ANDA211417, ANDA212399 | 13 | 1 |
| Lupin LimitedIndia | tablet | ANDAANDA209713 | 12 | 14 |
| AbbVie Inc.United States | tablet | NDANDA021402 | 12 | 13 |
| Macleods Pharmaceuticals LimitedIndia | tablet | ANDAANDA211417 | 12 | 5 |
| ACCORD HEALTHCARE LIMITEDUnited Kingdom | tablet | ANDAANDA212399 | 12 | 2 |
| ASCLEMED USA INC. DBA ENOVACHEMUnited States | tablet | ANDAANDA212399 | 12 | 1 |
| Amneal Ireland LimitedIreland | tablet | NDANDA021210 | 12 | 1 |
| Camber Pharmaceuticals, Inc.United States | tablet | ANDAANDA215259 | 12 | 1 |
| Lannett Company, LLCUnited States | tablet | NDA AUTHORIZED GENERICNDA021342 | 12 | 1 |
| XLCare Pharmaceuticals Inc.United States | tablet | ANDAANDA215259 | 12 | 1 |
| Amneal Pharmaceuticals NY LLC | tablet | NDA AUTHORIZED GENERICNDA021210 | 12 | 0 |
| Mylan Pharmaceuticals, Inc. | tablet | ANDAANDA076187 | 12 | 0 |
| YARAL Pharma Inc. | capsule | NDA AUTHORIZED GENERICNDA021924 | 12 | 0 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet | ANDAANDA209713 | 11 | 5 |
| NorthStar RxLLC | tablet | ANDAANDA211417 | 11 | 0 |
| Pfizer Laboratories Div Pfizer Inc | tablet | NDANDA021301 | 11 | 0 |
| NCS HealthCare of KY, LLC dba Vangard LabsUnited States | tablet | NDANDA021210 | 10 | 1 |
| Mylan Institutional Inc. | tablet | ANDAANDA076187 | 10 | 0 |
| MAJOR Pharmaceuticals Inc. | tablet | ANDAANDA209713 | 9 | 0 |
| Teva Pharmaceutical Industries Ltd.Canada | tablet | ANDAANDA207588 | 8 | 6 |
| Aurobindo Pharma LimitedIndia | tablet | ANDAANDA216414 | 5 | 6 |
| Provell Pharmaceuticals, LLC | tablet | NDANDA021292 | 5 | 0 |
| Fresenius Kabi USA, LLCUnited States | injection, solution | NDANDA210632 | 3 | 6 |
| RedPharm DrugUnited States | tablet | ANDAANDA212399 | 3 | 1 |
| Zydus Pharmaceuticals USA Inc.India | injection, powder, lyophilized, for solution | ANDAANDA217066 | 3 | 1 |
| PD-Rx Pharmaceuticals Inc.United States | tablet | ANDAANDA212399 | 2 | 1 |
| Piramal Critical Care IncUnited States | injection | ANDAANDA206163 | 2 | 1 |
| Zydus Lifesciences LimitedIndia | injection, powder, lyophilized, for solution | ANDAANDA217066 | 1 | 12 |
| Hikma Pharmaceuticals USA Inc.United States | injection, solution | NDANDA214253 | 1 | 4 |
| NuCar Pharmaceuticals,Inc. | tablet | NDANDA021116 | 1 | 0 |
| NuCarePharmaceuticals, Inc. | tablet | ANDAANDA209713 | 1 | 0 |
| Oliva Therapeutics, LLC | solution | NDANDA214047 | 1 | 0 |
Bulk ingredient listings
- MEDISCA Inc.United States · 2 NDC
- Peptido GmbHGermany · 2 NDC
- Sandoz Industrial Products S.AAustria · 2 NDC
- AZICO BIOPHORE INDIA PRIVATE LIMITEDIndia · 1 NDC
- Aurore Pharmaceuticals Private LimitedIndia · 1 NDC
- Excella GmbH & Co. KGGermany · 1 NDC
- FIS FABBRICA ITALIANA SINTETICI SPAItaly · 1 NDC
- INNOVA REMEDIES PRIVATE LIMITEDIndia · 1 NDC
- LETCO MEDICAL, LLCUnited States · 1 NDC
- Lupin LimitedIndia · 1 NDC
- MSN Laboratories Private Limited,India · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
- Valary Lab Private LimitedIndia · 1 NDC
Orange Book patents
16 unexpired patents list levothyroxine sodium as the active ingredient, expiring between Aug 2031 and Sept 2044. Application holders: FRESENIUS KABI USA LLC, GENUS LIFE SCIENCES INC, HIKMA PHARMACEUTICALS USA INC, IBSA INSTITUT BIOCHIMIQUE SA, JEROME STEVENS PHARMACEUTICALS INC, MYLAN PHARMACEUTICALS INC.
Enquiry
Common questions
- Who makes levothyroxine sodium?
- 43 companies list levothyroxine sodium as a human prescription drug in the openFDA NDC Directory, led by International Medication Systems, Ltd., Bryant Ranch Prepack, Northwind Health Company, LLC, IBSA Pharma Inc., Preferred Pharmaceuticals Inc.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic EUTHYROX?
- 29 companies list levothyroxine sodium under an abbreviated new drug application (ANDA), the application type used for generics, and 18 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies levothyroxine sodium active ingredient?
- 14 companies list levothyroxine sodium as a bulk ingredient, including MEDISCA Inc., Peptido GmbH, Sandoz Industrial Products S.A, AZICO BIOPHORE INDIA PRIVATE LIMITED.