Quick answers
- What is Neostigmine methylsulfate used for?
- The FDA-approved label (Bloxiverz, Exela Pharma Sciences, LLC, December 31, 2023) says: “BLOXIVERZ, is a cholinesterase inhibitor, indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery. BLOXIVERZ, is a cholinesterase inhibitor, indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Neostigmine methylsulfate have a boxed warning?
- No. None of the 29 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Neostigmine methylsulfate?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated January 12, 2026). Ask your pharmacist about alternatives.
- Has Neostigmine methylsulfate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Neostigmine methylsulfate?
- 23 companies list prescription products of Neostigmine methylsulfate in the FDA NDC Directory, including Fresenius Kabi USA, LLC, Medical Purchasing Solutions, LLC and Hikma Pharmaceuticals USA Inc..
What Neostigmine methylsulfate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
BLOXIVERZ, is a cholinesterase inhibitor, indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery. BLOXIVERZ, is a cholinesterase inhibitor, indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery.
— FDA label: Bloxiverz, Exela Pharma Sciences, LLC, effective December 31, 2023. Read the full label on DailyMed →
The FDA has 29 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 29 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection · Injection, solution |
|---|---|
| Route | Intravenous |
| Prescription products | 50 in the FDA NDC Directory |
| Brand names | Bloxiverz |
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.
- Fresenius Kabi USA, LLC7 products
- Medical Purchasing Solutions, LLC5 products
- Hikma Pharmaceuticals USA Inc.5 products
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.2 products
- Amneal Pharmaceuticals LLC2 products
- Somerset Therapeutics, LLC2 products
- Xellia Pharmaceuticals USA LLC2 products
- Amphastar Pharmaceuticals, Inc.2 products
- Camber Pharmaceuticals, Inc.2 products
- Meitheal Pharmaceuticals Inc.2 products
- Xiromed, LLC2 products
- Caplin Steriles Limited2 products
- Gland Pharma Limited2 products
- BE Pharmaceuticals Inc.2 products
- Indoco Remedies Limited2 products
- Eugia US LLC2 products
- Par Health USA, LLC2 products
- Dr. Reddy's Laboratories Inc.2 products
- Dr.Reddys Laboratories Inc1 product
- Exela Pharma Sciences, LLC1 product
- ProPharma Distribution1 product
- HF Acquisition Co LLC, DBA HealthFirst1 product
- Civica, 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 |
|---|---|---|---|
| NDA203629 NEOSTIGMINE METHYLSULFATE | Fresenius Kabi USA | January 8, 2015 | 2, latest February 4, 2021 2021: Labeling · 2015: Manufacturing (CMC) |
| NDA204078 BLOXIVERZ | Exela Pharma | May 31, 2013 | 8, latest October 27, 2023 2023: Manufacturing (CMC) · 2021: Labeling · 2015: Labeling |
Generic approvals (13)
- ANDA207042Hikma · December 28, 2015
- ANDA208405Ph Health · April 26, 2017
- ANDA209933Amphastar Pharms Inc · September 25, 2017
- ANDA210051Amneal · June 15, 2018
- ANDA209135DR Reddys · July 10, 2018
- ANDA212512Be Pharms · May 13, 2019
- ANDA212968Gland · October 16, 2019
- ANDA212804Meitheal · April 5, 2021
- ANDA213074Caplin · April 20, 2021
- ANDA210652Regcon Holdings · October 1, 2021
- ANDA216291DR Reddys · July 6, 2022
- ANDA208230Avet Lifesciences · November 25, 2022
- ANDA213244Eugia Pharma · November 2, 2023
Shortage status
To be discontinued · updated January 12, 2026 · first posted January 12, 2026
| Product | Neostigmine Methylsulfate, Injection, .5 mg/1 mL (NDC 63323-413-10) |
|---|---|
| Company | Fresenius Kabi USA, LLC |
Ask your pharmacist whether your product is affected and what the options are.
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) — Bloxiverz, Exela Pharma Sciences, LLC, effective December 31, 2023; 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 →