Medicine
Levothyroxine 50 mcg tablet
Levothyroxine 50 mcg tablet is a generic prescription medicine for oral use, made by 25 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C and 30°C…
Key facts
- Active ingredient (INN)
- Levothyroxine
- Brand
- Sold under the generic name
- Strength
- 50 mcg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 90 tablets, 1000 tablets, 100 tablets and 105 more
- Manufacturers
- Camber PharmaceuticalsIndiaLupinIndiaMacleods PharmaceuticalsIndiaAccord HealthcareIndiaA-S Medication SolutionsProficient RxAlvogenAmneal Pharmaceuticals NYLannettXLCare Pharmaceuticals25 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C and 30°C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- H03AA01 Levothyroxine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 December 2003
- Identifiers
- RxCUI 892246, 892251, 966220 +7DailyMed set ID 9e3bffb9-f66e-4c73-befc-e60d769f6610, d8bdea29-fc63-49b4-bc35-9029ec7b1bb9, 31a31756-68aa-4e01-bbb1-9d181f8d9181 +37NDC 71335-1502, 82804-314, 55154-3559 +37Application NDA021116, ANDA209713, ANDA207588 +6
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
A sample of 40 packs from 25 labelers. The register lists 108 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 90 tablet in 1 bottle | 16729-448-15 | Accord HealthcareIndia | 3 December 2020 |
| 1000 tablet in 1 bottle | 16729-448-17 | Accord HealthcareIndia | 25 November 2020 |
| 100 tablet in 1 bottle | 31722-285-01 | Camber PharmaceuticalsIndia | 18 January 2023 |
| 1000 tablet in 1 bottle | 31722-285-10 | Camber PharmaceuticalsIndia | 18 January 2023 |
| 30 tablet in 1 bottle | 31722-285-30 | Camber PharmaceuticalsIndia | 18 January 2023 |
| 90 tablet in 1 bottle | 31722-285-90 | Camber PharmaceuticalsIndia | 18 January 2023 |
| 100 tablet in 1 bottle | 68180-966-01 | LupinIndia | 2 May 2019 |
| 1000 tablet in 1 bottle | 68180-966-03 | LupinIndia | 2 May 2019 |
| 90 tablet in 1 bottle | 68180-966-09 | LupinIndia | 2 May 2019 |
| 90 tablet in 1 bottle | 33342-394-10 | Macleods PharmaceuticalsIndia | 21 December 2022 |
| 100 tablet in 1 bottle | 33342-394-11 | Macleods PharmaceuticalsIndia | 21 December 2022 |
| 1000 tablet in 1 bottle | 33342-394-44 | Macleods PharmaceuticalsIndia | 24 January 2023 |
| 1000 tablet in 1 bottle | 47781-643-10 | Alvogen | 7 May 2019 |
| 90 tablet in 1 bottle | 47781-643-90 | Alvogen | 7 May 2019 |
| 100 tablet in 1 bottle, plastic | 69238-1831-1 | Amneal Pharmaceuticals NY | 1 December 2003 |
| 1000 tablet in 1 bottle, plastic | 69238-1831-7 | Amneal Pharmaceuticals NY | 1 December 2003 |
| 1000 tablet in 1 bottle | 0527-3281-43 | Lannett | 3 August 2020 |
| 90 tablet in 1 bottle | 0527-3281-46 | Lannett | 3 August 2020 |
| 100 blister pack in 1 carton / 1 tablet in 1 blister pack | 51079-440-20 | Mylan Institutional | 5 February 2007 |
| 1000 tablet in 1 bottle | 72865-237-10 | XLCare Pharmaceuticals | 18 January 2023 |
| 90 tablet in 1 bottle | 72865-237-90 | XLCare Pharmaceuticals | 18 January 2023 |
| 30 tablet in 1 bottle | 50090-6090-0 | A-S Medication Solutions | 21 September 2022 |
| 90 tablet in 1 bottle | 50090-6090-1 | A-S Medication Solutions | 21 September 2022 |
| 30 tablet in 1 bottle | 50090-6569-0 | A-S Medication Solutions | 31 July 2023 |
| 90 tablet in 1 bottle | 50090-6569-1 | A-S Medication Solutions | 31 July 2023 |
| 90 tablet in 1 bottle | 50090-6572-0 | A-S Medication Solutions | 1 August 2023 |
| 90 tablet in 1 bottle | 50090-6594-0 | A-S Medication Solutions | 18 August 2023 |
| 90 tablet in 1 bottle | 50090-6660-0 | A-S Medication Solutions | 30 August 2023 |
| 30 tablet in 1 bottle | 50090-7562-0 | A-S Medication Solutions | 28 May 2025 |
| 90 tablet in 1 bottle | 50090-7562-1 | A-S Medication Solutions | 28 May 2025 |
| 90 tablet in 1 bottle | 50090-7563-0 | A-S Medication Solutions | 28 May 2025 |
| 30 tablet in 1 bottle | 50090-8060-0 | A-S Medication Solutions | 15 September 2026 |
| 90 tablet in 1 bottle | 50090-8060-1 | A-S Medication Solutions | 15 September 2026 |
| 30 tablet in 1 bottle, plastic | 71205-242-30 | Proficient Rx | 1 March 2019 |
| 60 tablet in 1 bottle, plastic | 71205-242-60 | Proficient Rx | 1 March 2019 |
| 90 tablet in 1 bottle, plastic | 71205-242-90 | Proficient Rx | 1 March 2019 |
| 30 tablet in 1 bottle | 71205-352-30 | Proficient Rx | 1 November 2019 |
| 60 tablet in 1 bottle | 71205-352-60 | Proficient Rx | 1 November 2019 |
| 90 tablet in 1 bottle | 71205-352-90 | Proficient Rx | 1 November 2019 |
| 30 tablet in 1 bottle | 71205-646-30 | Proficient Rx | 22 March 2022 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 21 August 2000 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Levothyroxine 50 mcg tablet.
Other strengths and forms of Levothyroxine
Clinical summary
Levothyroxine is a l-thyroxine. It is available as tablets, capsules and powder for injection for oral and intravenous use. MedsAcross supplies Levothyroxine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about LevothyroxineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Levothyroxine Sodium prescribing information (Amneal Pharmaceuticals NY) · U.S. National Library of Medicine, DailyMed
Need Levothyroxine 50 mcg tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.