Hydroxocobalamin

Hydroxocobalamin is an FDA-registered drug product whose active ingredient is HYDROXOCOBALAMIN. It is labelled by Xseer Pharmaceuticals taken by intramuscular and marketed as a human prescription drug product. Identifiers on file: NDC 85551-125, label effective 20260515. It is one of 3 FDA drug label records sharing the active ingredient HYDROXOCOBALAMIN. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing HYDROXOCOBALAMIN are most often described in connection with: vitamin deficiency, intrinsic factor, cyanokit indicated, treatment known, suspected cyanide, gastric atrophy, usage pernicious, accompanied nervous. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Contraindications Hydroxocobalamin Injection is contraindicated in patients with known hypersensitivity to hydroxocobalamin, vitamin B12 preparations, cobalt, benzyl alcohol, or any component of the formulation. Hypersensitivity reactions, including anaphylactic shock and serious allergic reactions, have been reported following parenteral administration of hydroxocobalamin and other vitamin B12 products. Administration to patients with hereditary optic nerve atrophy (Leber’s disease) may result in severe and rapid optic nerve atrophy.

Adverse Reactions The following adverse reactions have been reported with hydroxocobalamin injection and other parenteral vitamin B12 products: Hypersensitivity reactions including anaphylactic shock, urticaria, rash, pruritus, flushing, and edema Injection site pain, erythema, and injection site reactions Headache and dizziness Nausea and diarrhea Fever and chills Rare cases of hypokalemia during intensive treatment of severe megaloblastic anemia Serious hypersensitivity reactions, including anaphylaxis, may occur in sensitive patients. To report suspected adverse reactions, contact Xseer Pharmaceuticals at (888) 658-8005 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

FDA lists 3 drug label records with HYDROXOCOBALAMIN as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Hydroxocobalamin used for?
The FDA label on file for this product does not include a full indications section. Other FDA labels sharing the active ingredient HYDROXOCOBALAMIN describe it in connection with: vitamin deficiency, intrinsic factor, cyanokit indicated, treatment known, suspected cyanide, gastric atrophy, usage pernicious, accompanied nervous. Check the specific product label or ask a prescriber before use.

Who makes Hydroxocobalamin?
Xseer Pharmaceuticals is the labeler of record for Hydroxocobalamin. 3 FDA label records share the active ingredient HYDROXOCOBALAMIN, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Hydroxocobalamin come in?
administered by intramuscular. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Hydroxocobalamin prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing HYDROXOCOBALAMIN?
Yes. 3 FDA drug label records list HYDROXOCOBALAMIN as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Hydroxocobalamin been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.