Quick answers
- What is Sugammadex used for?
- The FDA-approved label (Bridion, Merck Sharp & Dohme LLC, March 13, 2026) says: “BRIDION ® is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients undergoing surgery. BRIDION is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients undergoing surgery.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Sugammadex have a boxed warning?
- No. None of the 25 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Sugammadex?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Sugammadex been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Sugammadex?
- 25 companies list prescription products of Sugammadex in the FDA NDC Directory, including Steriscience Specialties Private Limited, Dr. Reddy's Laboratories Inc. and Zydus Lifesciences Limited.
What Sugammadex is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
BRIDION ® is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients undergoing surgery. BRIDION is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients undergoing surgery.
— FDA label: Bridion, Merck Sharp & Dohme LLC, effective March 13, 2026. Read the full label on DailyMed →
The FDA has 25 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 25 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Solution · Injection |
|---|---|
| Route | Intravenous |
| Prescription products | 44 in the FDA NDC Directory |
| Brand names | Bridion |
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.
- Steriscience Specialties Private Limited2 products
- Dr. Reddy's Laboratories Inc.2 products
- Zydus Lifesciences Limited2 products
- Medical Purchasing Solutions, LLC2 products
- Accord Healthcare Inc.2 products
- Par Health USA, LLC2 products
- Zydus Pharmaceuticals USA Inc.2 products
- Lupin Pharmaceuticals, Inc.2 products
- Novadoz Pharmaceuticals LLC2 products
- Sandoz Inc2 products
- Camber Pharmaceuticals, Inc.2 products
- Shandong New Time Pharmaceutical Co., Ltd.2 products
- Mylan Institutional LLC2 products
- Solupharm Pharmazeutische Erzeugnisse GmbH2 products
- Merck Sharp & Dohme LLC2 products
- Gland Pharma Limited2 products
- Glenmark Pharmaceuticals Inc., USA2 products
- Somerset Therapeutics, LLC2 products
- Fosun Pharma USA Inc.2 products
- B. Braun Medical Inc.1 product
- Sagent Pharmaceuticals1 product
- Fresenius Kabi USA, LLC1 product
- Hikma Pharmaceuticals USA Inc.1 product
- ProPharma Distribution1 product
- Sun Pharmaceutical Industries, 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 |
|---|---|---|---|
| NDA022225 BRIDION | Msd Sub Merck | December 15, 2015 | 7, latest December 12, 2024 2024: Efficacy · 2022: Labeling · 2021: Efficacy |
Generic approvals (17)
- ANDA214337Aspiro · June 9, 2023
- ANDA214290Zydus Pharms · October 4, 2023
- ANDA214279B Braun Medical · August 5, 2025
- ANDA213915Mylan · July 28, 2026
- ANDA214236DR Reddys · July 28, 2026
- ANDA214306Zenara · July 28, 2026
- ANDA214311Sandoz · July 28, 2026
- ANDA214319Sun Pharm Inds Inc · July 28, 2026
- ANDA214338Lupin · July 28, 2026
- ANDA214364Gland · July 28, 2026
- ANDA214368Msn · July 28, 2026
- ANDA215260Tamarang · July 28, 2026
- ANDA215575Qilu Pharm Hainan · July 28, 2026
- ANDA218727Hikma · July 28, 2026
- ANDA218814Steriscience · July 28, 2026
- ANDA219448Fresenius Kabi USA · July 28, 2026
- ANDA215701Shandong · October 6, 2026
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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Bridion, Merck Sharp & Dohme LLC, effective March 13, 2026; 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 →