Quick answers
- What is Iron dextran used for?
- The FDA-approved label (Infed, Henry Schein, Inc., April 15, 2026) says: “INFeD is indicated for treatment of adult and pediatric patients of age 4 months and older with documented iron deficiency who have intolerance to oral iron or have had an unsatisfactory response to oral iron. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Iron dextran have a boxed warning?
- Yes. The FDA label for Infed has a boxed warning (“WARNING: RISK FOR ANAPHYLACTIC-TYPE REACTIONS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Iron dextran?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Iron dextran been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Iron dextran?
- 3 companies list prescription products of Iron dextran in the FDA NDC Directory, including Allergan, Inc., Henry Schein, Inc. and HF Acquisition Co LLC, DBA HealthFirst.
What Iron dextran is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
INFeD is indicated for treatment of adult and pediatric patients of age 4 months and older with documented iron deficiency who have intolerance to oral iron or have had an unsatisfactory response to oral iron. …
— FDA label: Infed, Henry Schein, Inc., effective April 15, 2026. Read the full label on DailyMed →
The FDA has 3 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.
This label has a boxed warning. Its heading: WARNING: RISK FOR ANAPHYLACTIC-TYPE REACTIONS
. Read it on the full label →
3 of 3 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection |
|---|---|
| Route | Intramuscular · Intravenous |
| Prescription products | 3 in the FDA NDC Directory |
| Brand names | Infed |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| iron dextran 50 mg/mL injection | Brand: INFeD | $18.93 per mL |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
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.
- Allergan, Inc.1 product
- Henry Schein, Inc.1 product
- HF Acquisition Co LLC, DBA HealthFirst1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA017441 INFED | Allergan | April 29, 1974 | 145, latest August 1, 2024 2024: Labeling · 2021: Labeling · 2021: Labeling |
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
| RxCUI (RxNorm) | 206216, 311144 |
|---|---|
| SPL set ID of the quoted label | 99bf34be-cb8a-46d1-9637-5544dc2da287 |
| FDA labels (SPL) | 3 |
| FDA applications | NDA017441 |
| Active ingredients (FDA) | IRON DEXTRAN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Infed, Henry Schein, Inc., effective April 15, 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 →