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Medicine

Purified Cortrophin Gel 80 units/mL injection

Corticotropin · Intramuscular, subcutaneous · ANI Pharmaceuticals
Available on requestPrescription onlyUS FDA Cold chain

Purified Cortrophin Gel 80 units/mL injection is a prescription medicine containing Corticotropin for intramuscular, subcutaneous use, marketed by ANI Pharmaceuticals, 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

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Cold chain

Store Purified Cortrophin Gel vials and prefilled syringes refrigerated at 2°…

Key facts

Active ingredient (INN)
Corticotropin
Brand
Purified Cortrophin Gel
Strength
80 units/mL
Dosage form
Injection
Route
Intramuscular, subcutaneous
Packs
1 vial
Marketing authorisation holder
ANI Pharmaceuticals
Manufacturer
ANI Pharmaceuticals
Origin register
US FDA, United States
Storage
Store Purified Cortrophin Gel vials and prefilled syringes refrigerated at 2° to 8°C (36° to 46°F). Purified Cortrophin Gel vials and prefilled syringes may be stored at room temperature between 20° to 25°C (68° 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 October 2021
Identifiers
RxCUI 309541, 2584475, 2685293 +3DailyMed set ID f27544ee-a0e2-4d84-b193-1c9efdf9e34cNDC 62559-860Application NDA008975

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

PackCodeLabelerMarketed since
1 vial, multi-dose in 1 carton / 1 mL in 1 vial, multi-dose62559-860-11ANI Pharmaceuticals14 August 2023
1 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose62559-860-15ANI Pharmaceuticals29 October 2021

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 3 July 1950Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS 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 Corticotropin 80 units/mL injection.

Compare all 2

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 Corticotropin

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Purified Cortrophin Gel 80 units/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.