Quick answers
- What is Cosyntropin used for?
- The FDA-approved label (Cortrosyn, Amphastar Pharmaceuticals, Inc., January 30, 2025) says: “CORTROSYN 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.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Cosyntropin have a boxed warning?
- No. None of the 5 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Cosyntropin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Cosyntropin been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Cosyntropin?
- 5 companies list prescription products of Cosyntropin in the FDA NDC Directory, including Medical Purchasing Solutions, LLC, HF Acquisition Co LLC, DBA HealthFirst and Henry Schein, Inc..
What Cosyntropin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
CORTROSYN 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 label: Cortrosyn, Amphastar Pharmaceuticals, Inc., effective January 30, 2025. Read the full label on DailyMed →
The FDA has 5 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 5 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous · Intramuscular · Parenteral |
| Prescription products | 6 in the FDA NDC Directory |
| Brand names | Cortrosyn |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Medical Purchasing Solutions, LLC2 products
- HF Acquisition Co LLC, DBA HealthFirst1 product
- Henry Schein, Inc.1 product
- Sandoz Inc1 product
- Amphastar Pharmaceuticals, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA016750 CORTROSYN | Amphastar Pharms Inc | April 22, 1970 | 19, latest December 22, 2023 2023: Labeling · 2021: Labeling · 2014: Manufacturing (CMC) |
Generic approvals (1)
- ANDA202147Sandoz · June 29, 2012
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| SPL set ID of the quoted label | 746856e9-3930-4f6a-b8e6-a03845d6dd0b |
|---|---|
| FDA labels (SPL) | 5 |
| FDA applications | NDA016750, 1 ANDA |
| Active ingredients (FDA) | COSYNTROPIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Cortrosyn, Amphastar Pharmaceuticals, Inc., effective January 30, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →