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Dalteparin

Generic Name
Dalteparin
Brand Names
Fragmin
Drug Type
Small Molecule
CAS Number
9005-49-6
Unique Ingredient Identifier
S79O08V79F

Overview

Dalteparin, a low molecular weight heparin (LMWH) prepared by nitrous acid degradation of unfractionated heparin of porcine intestinal mucosa origin, is an anticoagulant. It is composed of strongly acidic sulphated polysaccharide chains with an average molecular weight of 5000 and about 90% of the material within the range of 2000-9000. LMWHs have a more predictable response, a greater bioavailability, and a longer anti-Xa half life than unfractionated heparin. Dalteparin can also be safely used in most pregnant women. Low molecular weight heparins are less effective at inactivating factor IIa due to their shorter length compared to unfractionated heparin.

Indication

Dalteparin is used as a prophylaxis for deep-vein thrombosis and pulmonary embolisms in patients undergoing general surgery (e.g., abdominal, gynecologic, urologic), and in patients with acute medical conditions (e.g. cancer, bed rest, heart failure, severe lung disease). It is also used in patients who have severely restricted mobility, which poses a risk for thromboembolic complications. Dalteparin is also used concomitantly with aspirin and/or other therapy (e.g., nitrates, β-adrenergic blockers, clopidogrel, platelet glycoprotein [GP] IIb/IIIa-receptor inhibitors) to reduce the risk of acute cardiac ischemic events. The patients who undergo this treatment combination have unstable angina or non-ST-segment elevation/non-Q-wave myocardial infarction (i.e., non-ST-segment elevation acute coronary syndromes). It is also used in the prevention of clotting during hemodialysis and hemofiltration in connection with acute renal failure or chronic renal insufficiency.

Associated Conditions

  • Cardiovascular Events
  • Clotting
  • Deep Vein Thrombosis
  • Symptomatic Venous Thromboembolism
  • Venous Thromboembolism

Research Report

Published: Jul 26, 2025

Dalteparin Sodium (Fragmin®): A Comprehensive Pharmacological and Clinical Monograph

Introduction and Drug Identification

Overview of Dalteparin as a Low Molecular Weight Heparin (LMWH)

Dalteparin is a potent antithrombotic agent belonging to the class of low molecular weight heparins (LMWHs). It is a biological product derived from unfractionated heparin (UFH) of porcine intestinal mucosa origin through a controlled process of nitrous acid depolymerization.[1] This process yields a complex mixture of strongly acidic sulphated polysaccharide chains with an average molecular weight of approximately 5000 Daltons; about 90% of the material falls within the 2000 to 9000 Dalton range.[1] The resulting product, dalteparin sodium, functions as an anticoagulant, commonly referred to as a "blood thinner," and is clinically utilized for the prophylaxis and treatment of thromboembolic disorders, including deep vein thrombosis (DVT) and pulmonary embolism (PE).[3]

Marketed globally under the brand name Fragmin®, dalteparin holds a significant place in modern antithrombotic therapy.[3] Its development represented a substantial advancement over its parent compound, UFH. Dalteparin exhibits several key advantages, including a more predictable pharmacokinetic profile, superior bioavailability following subcutaneous administration, and a longer biological half-life. These properties permit reliable weight-based dosing, typically via self-administered subcutaneous injection, and reduce or eliminate the need for the intensive laboratory monitoring required for UFH therapy.[1] In recognition of its efficacy, safety, and critical role in healthcare, dalteparin is included on the World Health Organization's List of Essential Medicines.[3]

Key Identifiers and Chemical Properties

Continue reading the full research report

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Pfizer Laboratories Div Pfizer Inc
0069-0220
SUBCUTANEOUS
12500 [iU] in 0.5 mL
8/15/2022
Pfizer Laboratories Div Pfizer Inc
0069-0232
SUBCUTANEOUS
25000 [iU] in 1 mL
8/15/2022
Pfizer Laboratories Div Pfizer Inc
0069-0253
SUBCUTANEOUS
2500 [iU] in 1 mL
8/15/2022
Pfizer Laboratories Div Pfizer Inc
0069-0223
SUBCUTANEOUS
15000 [iU] in 0.6 mL
8/15/2022
Pfizer Laboratories Div Pfizer Inc
0069-0228
SUBCUTANEOUS
18000 [iU] in 0.72 mL
8/15/2022
Pfizer Laboratories Div Pfizer Inc
0069-0196
SUBCUTANEOUS
5000 [iU] in 0.2 mL
8/15/2022
Pfizer Laboratories Div Pfizer Inc
0069-0195
SUBCUTANEOUS
2500 [iU] in 0.2 mL
8/15/2022
Pfizer Laboratories Div Pfizer Inc
0069-0206
SUBCUTANEOUS
7500 [iU] in 0.3 mL
8/15/2022
Pfizer Laboratories Div Pfizer Inc
0069-0217
SUBCUTANEOUS
10000 [iU] in 1 mL
8/15/2022

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
FRAGMIN INJECTION 2500 iu/ml
SIN05249P
INJECTION
2500 iu/ml
12/3/1990

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.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
FRAGMIN
02494582
Solution - Intravenous ,  Subcutaneous
16500 UNIT / 0.66 ML
6/8/2020
FRAGMIN
02352664
Solution - Intravenous ,  Subcutaneous
12500 UNIT / 0.5 ML
2/1/2011
FRAGMIN
02132664
Solution - Intravenous ,  Subcutaneous
10000 UNIT / ML
12/31/1995
FRAGMIN
02132648
Solution - Subcutaneous ,  Intravenous
5000 UNIT / 0.2 ML
12/31/1995
FRAGMIN
02352672
Solution - Subcutaneous ,  Intravenous
15000 UNIT / 0.6 ML
2/1/2011
FRAGMIN
02430789
Solution - Intravenous ,  Subcutaneous
3500 UNIT / 0.28 ML
3/25/2015
FRAGMIN
02377454
Solution - Subcutaneous ,  Intravenous
2500 UNIT / ML
7/25/2012
FRAGMIN
02132621
Solution - Subcutaneous ,  Intravenous
2500 UNIT / 0.2 ML
12/31/1995
FRAGMIN
02352680
Solution - Intravenous ,  Subcutaneous
18000 UNIT / 0.72 ML
2/1/2011
FRAGMIN
02231171
Solution - Subcutaneous ,  Intravenous
25000 UNIT / ML
11/27/1997

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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