Prescription medicine
Corticotropin Brand names: Acthar, Purified
Corticotropin (Purified) is a prescription medicine with an FDA approval on record since 1950. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the corticotropin FDA label on DailyMed (effective July 15, 2026, Mallinckrodt ARD LLC); the NDA 7504 record on Drugs@FDA; every corticotropin label on DailyMed.
Highlights of the record
FDA label of July 15, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageActhar Gel is indicated as monotherapy for the treatment of infantile spasms in infants and children under 2 years of age.
Forms and strengths
- 0.5ml
Injection.
On the market
- Earliest approval on file
- July 3, 1950 Acthar, Sanofi Aventis Us; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- October 27, 2043 Purified Cortrophin Gel injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2024 0 Class I among all firms' recalls; latest August 6, 2026
- FAERS reports
- 2,727 through July 30, 2026
What is corticotropin used for?
From the label: indications and usageActhar Gel is indicated as monotherapy for the treatment of infantile spasms in infants and children under 2 years of age. ( 1.1 ) Acthar Gel is indicated for the treatment of exacerbations of multiple sclerosis in adults. ( 1.2 ) Acthar Gel may be used for the following disorders and diseases: rheumatic ( 1.3 ); collagen ( 1.4 ); dermatologic ( 1.5 ); allergic states ( 1.6 ); ophthalmic ( 1.7 ); respiratory ( 1.8 ); and edematous state. […]
Conditions named in the indications of corticotropin's FDA labels, with every medicine labeled for each:
From other corticotropin labelsPsoriasis: Severe psoriasis.
Eczema (atopic dermatitis): Atopic dermatitis Serum sickness.
FDA pharmacologic class: Adrenocorticotropic Hormone.
Source: FDA drug label (Acthar), Mallinckrodt ARD LLC, effective July 15, 2026 (SPL set 7b48ddec-e815-45f4-9ca0-5c0daaf56f30), via openFDA; the full label on DailyMed
What does the patient leaflet for corticotropin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about Acthar Gel?Acthar Gel can cause serious side effects including: 1. Increased risk of infections. Acthar Gel is a medicine that can affect your child's immune system. When your child is taking Acthar Gel, it can lower the ability of your child's immune system to fight infections. […] During treatment and after treatment ends, tell your doctor if your child has: any signs or symptoms of infection. See number 1 of this section in the Medication Guide. changes in body weight bloody or black tarry stool vomiting stomach pain excessive tiredness increased thirst fast heart rate difficulty breathing 6. Stomach and intestinal problems. Acthar Gel may cause bleeding of the stomach or intestine. Your child has an increased risk for bleeding from the stomach or having a stomach ulcer. Tell your doctor if your child has any pain in the stomach area (abdominal pain), vomits blood, or has bloody or black stools. 7. Changes in mood and behavior. […]
From the patient leaflet: How should I store Acthar Gel?Store vials of Acthar Gel in the refrigerator between 36°F to 46°F (2°C to 8°C). Throw away any vials after the expiration date printed on the label. Keep Acthar Gel and all other medicines out of the reach of children General information About Acthar Gel Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Acthar Gel for a condition for which it has not been prescribed. Do not give Acthar Gel to other people, even if they have the same symptoms. It may harm them. This Medication Guide summarizes the most important information about Acthar Gel. If you would like more information, talk with your child's doctor. You can ask your child's doctor or pharmacist for information about Acthar Gel that is written for healthcare professionals. For more information, go to www.acthar.com or call 1-800-844-2830.
Source: FDA drug label (Acthar), Mallinckrodt ARD LLC, effective July 15, 2026 (SPL set 7b48ddec-e815-45f4-9ca0-5c0daaf56f30), via openFDA; the full label on DailyMed
Is there a generic for corticotropin (Purified)?
No generic corticotropin is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 5 patents for Purified Cortrophin Gel injection, the last expiring on October 27, 2043. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1950 earliest approval on file
- 2043 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has corticotropin been recalled?
The FDA's Enforcement Report lists 2 recalls naming corticotropin since 2024: 0 Class I (the most serious), 2 Class II, 0 Class III; 2 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 6, 2026 | Class II | Mallinckrodt Hospital Products Inc. | Presence of particulate matter: glass and stopper piece |
| February 6, 2024 | Class II | Mallinckrodt Hospital Products Inc. | cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the corticotropin label say about other medicines?
The corticotropin label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 15 other medicines name corticotropin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aspirin | drug interactions | Drug Interactions Aspirin should be used cautiously in conjunction with corticotropin in hypoprothrombinemia. |
Other labels that name corticotropin
Source: FDA drug label (Acthar), Mallinckrodt ARD LLC, effective July 15, 2026 (SPL set 7b48ddec-e815-45f4-9ca0-5c0daaf56f30), via openFDA; the full label on DailyMed
What do FAERS reports show for corticotropin?
The FDA Adverse Event Reporting System holds 2,727 reports that list corticotropin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 46 are coded as a death and 373 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as corticotropin?
4 other medicines are given the same way (subcutaneous) and in the same FDA class as corticotropin or labeled mainly for the same use (multiple sclerosis), the same class first. Multiple sclerosis lists all 23 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (subcutaneous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Glatiramer | Multiple sclerosis | 8 labelers | $86.10 per mL 40 mg/mL syringe | No current entry |
| Interferon beta 1a | Multiple sclerosis | none listed | $1,848.67 per mL 44 mcg/0.5 mL | No current entry |
| Peginterferon beta 1a | Multiple sclerosis | none listed | n/a | No current entry |
| Ofatumumab | Multiple sclerosis | none listed | $24,369.37 per mL 20 mg/0.4 mL pen | No current entry |
Every medicine labeled for the same conditions as corticotropin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to corticotropin
- 4 medicines for the same use
- Other adrenocorticotropic hormones
- the pharmacologic class, with prices and generics
- Corticotropin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other