Medicine
Acthar 40 units/0.5 mL injection
Acthar 40 units/0.5 mL injection is a prescription medicine containing Corticotropin for subcutaneous use, marketed by Keenova ARD, 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. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store Acthar Gel vial and Acthar Gel single-dose pre-filled SelfJect injector…
Key facts
- Active ingredient (INN)
- Corticotropin
- Brand
- Acthar
- Strength
- 40 units/0.5 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 4 trays
- Marketing authorisation holder
- Keenova ARD
- Manufacturer
- Keenova ARD
- Origin register
- US FDA, United States
- Storage
- Store Acthar Gel vial and Acthar Gel single-dose pre-filled SelfJect injector under refrigeration between 2°C to 8°C (36°F to 46°F) in the carton to protect from light. After removing the single-dose pre-filled SelfJect injector from the refrigerator, it can be stored at room temperature between 20°C to 25°C (68°F to 77°F) for up to 24 hours.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- H01AA01 Corticotropin
- HS code (indicative)
- 3004.39Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 29 February 2024
- Identifiers
- RxCUI 309541, 1040025, 2685293 +3DailyMed set ID 7b48ddec-e815-45f4-9ca0-5c0daaf56f30NDC 63004-8711, 63004-8712Application NDA008372
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 4 tray in 1 carton / 1 syringe in 1 tray / 1 mL in 1 syringe | 63004-8711-4 | Keenova ARD | 29 February 2024 |
| 4 tray in 1 carton / 1 syringe in 1 tray / .5 mL in 1 syringe | 63004-8712-4 | Keenova ARD | 29 February 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 3 July 1950 | 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 Corticotropin
Clinical summary
Corticotropin is an adrenocorticotropic hormone indicated as monotherapy for the treatment of infantile spasms in infants and children under 2 years of age, among other approved uses. It is available as injection for subcutaneous and intramuscular use. MedsAcross supplies Corticotropin 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 CorticotropinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Acthar prescribing information (Keenova ARD) · U.S. National Library of Medicine, DailyMed
Need Acthar 40 units/0.5 mL 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.