Prescription medicine
Cosyntropin Brand names: Cortrosyn
Cosyntropin (Cortrosyn) is a prescription medicine with an FDA approval on record since 1970. FDA's NDC Directory lists it from 3 generic labelers.
- Generic listed
Check it at the source: the cosyntropin FDA label on DailyMed (effective January 30, 2025, Amphastar Pharmaceuticals, Inc.); the NDA 16750 record on Drugs@FDA; every cosyntropin label on DailyMed.
Highlights of the record
FDA label of January 30, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageCORTROSYN is indicated, in combination with other diagnostic tests, for use as a diagnostic agent in the screening of adrenocortical insufficiency in adults and pediatric patients.
Forms and strengths
- 0.25 mg/ml
Injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- April 22, 1970 Cortrosyn, Amphastar Pharms Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first December 17, 2009; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 5 of which 3 under generic applications, 3 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 217 through July 30, 2026
What is cosyntropin used for?
From the label: indications and usageCORTROSYN is indicated, in combination with other diagnostic tests, for use as a diagnostic agent in the screening of adrenocortical insufficiency in adults and pediatric patients. CORTROSYN is an adrenocorticotropin hormone indicated, in combination with other diagnostic tests, for use as a diagnostic agent in the screening of adrenocortical insufficiency in adults and pediatric patients.
FDA pharmacologic class: Adrenocorticotropic Hormone.
Source: FDA drug label (Cortrosyn), Amphastar Pharmaceuticals, Inc., effective January 30, 2025 (SPL set 746856e9-3930-4f6a-b8e6-a03845d6dd0b), via openFDA; the full label on DailyMed
Is there a generic for cosyntropin (Cortrosyn)?
The FDA approved the first generic cosyntropin on December 17, 2009. 2 generic applications are approved; 1 of them carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists cosyntropin from 3 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1970 earliest approval on file
- 2009 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the cosyntropin label say about other medicines?
The cosyntropin label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 4 other medicines name cosyntropin. 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 |
|---|---|---|
| Spironolactone | drug interactions | DRUG INTERACTIONS Drug effects on plasma cortisol levels: ◦ Accuracy of the test results can be affected by concomitant medications. ◦ Glucocorticoids and spironolactone: |
Source: FDA drug label (Cortrosyn), Amphastar Pharmaceuticals, Inc., effective January 30, 2025 (SPL set 746856e9-3930-4f6a-b8e6-a03845d6dd0b), via openFDA; the full label on DailyMed
What do FAERS reports show for cosyntropin?
The FDA Adverse Event Reporting System holds 217 reports that list cosyntropin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 27 are coded as a death and 95 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.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other adrenocorticotropic hormones
- the pharmacologic class, with prices and generics
- Cosyntropin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other