MedPath

Iron Dextran

Generic Name
Iron Dextran
Brand Names
Infed, Irospan 24/6 Kit
Drug Type
Small Molecule
CAS Number
9004-66-4
Unique Ingredient Identifier
95HR524N2M

Overview

Iron dextran is a dark brown, slightly viscous liquid complex of ferric hydroxide and dextran for intravenous or intramuscular use. Iron Dextran is used for the treatment of patients with documented iron deficiency in which oral administration is unsatisfactory or impossible.

Indication

For treatment of patients with documented iron deficiency in whom oral administration is unsatisfactory or impossible. Also used to replenish body iron stores in Non-Dialysis Dependent-Chronic Kidney Disease (NDD-CKD) patients receiving or not receiving erythropoietin and in Hemodialysis Dependent (HDD-CKD) and Peritoneal Dialysis Dependent (PDD-CKD) - Chronic Kidney Disease patients receiving an erythropoietin.

Associated Conditions

  • Iron Deficiency (ID)

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
HF Acquisition Co LLC, DBA HealthFirst
51662-1441
INTRAMUSCULAR, INTRAVENOUS
50 mg in 1 mL
2/22/2020
PureTek Corporation
59088-112
ORAL
53 mg in 1 1
1/11/2023
Henry Schein, Inc.
0404-9879
INTRAMUSCULAR, INTRAVENOUS
50 mg in 1 mL
1/11/2022
Avion Pharmaceuticals, LLC
75854-321
ORAL
100 mg in 1 1
1/7/2021
Allergan, Inc.
0023-6082
INTRAMUSCULAR, INTRAVENOUS
50 mg in 1 mL
2/23/2024
Pharmacosmos, Inc
42552-741
INTRAMUSCULAR
200 mg in 1 mL
4/9/2025
General Injectables & Vaccines, Inc.
52584-086
INTRAMUSCULAR, INTRAVENOUS
50 mg in 1 mL
12/22/2022

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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