Medicine
Levothyroxine 500 mcg/5 mL powder for injection
Levothyroxine 500 mcg/5 mL powder for injection is a generic prescription medicine for intravenous use, made by 6 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
Protect from light and store dry product at 20° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Levothyroxine
- Brand
- Sold under the generic name
- Strength
- 500 mcg/5 mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 1 vial and 4 more
- Manufacturers
- Zydus LifesciencesIndiaFresenius KabiEndoMAIA PharmaceuticalsOnesource Specialty PharmaSagent Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Protect from light and store dry product at 20° to 25°C (68° to 77°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
- 24 June 2011
- Identifiers
- RxCUI 966219, 1115267, 1115269DailyMed set ID ce990712-49c1-4f66-9ee4-c770e8ec394c, f57e9b19-6f17-4520-80fc-511322cc56c9, ae9954a5-e196-449c-abea-ebe4afbee517 +4NDC 63323-648, 25021-470, 83270-008 +3Application NDA202231, ANDA208749, ANDA216729 +1
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 70710-1835-1 | Zydus LifesciencesIndia | 1 November 2024 |
| 1 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 63323-648-10 | Fresenius Kabi | 24 June 2011 |
| 1 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 63323-648-94 | Fresenius Kabi | 24 June 2011 |
| 1 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 42023-203-01 | Endo | 24 June 2011 |
| 1 vial, single-use in 1 carton / 5 mL in 1 vial, single-use | 70511-113-10 | MAIA Pharmaceuticals | 27 December 2018 |
| 1 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 83270-008-01 | Onesource Specialty Pharma | 27 April 2026 |
| 1 vial in 1 carton / 5 mL in 1 vial | 25021-470-10 | Sagent Pharmaceuticals | 1 January 2024 |
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
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 500 mcg/5 mL powder for injection 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.