Quick answers
- What is Dalteparin sodium used for?
- The FDA-approved label (Fragmin, Pfizer Laboratories Div Pfizer Inc, September 30, 2025) says: “FRAGMIN is a low molecular weight heparin (LMWH) indicated for • Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction • Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery or medical patients with severely restricted mobility during acute illness • Extended treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Dalteparin sodium have a boxed warning?
- Yes. The FDA label for Fragmin has a boxed warning (“WARNING: SPINAL/EPIDURAL HEMATOMAS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Dalteparin sodium?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Dalteparin sodium been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Dalteparin sodium?
- 1 company lists prescription products of Dalteparin sodium in the FDA NDC Directory, including Pfizer Laboratories Div Pfizer Inc.
What Dalteparin sodium is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
FRAGMIN is a low molecular weight heparin (LMWH) indicated for • Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction • Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery or medical patients with severely restricted mobility during acute illness • Extended treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in …
— FDA label: Fragmin, Pfizer Laboratories Div Pfizer Inc, effective September 30, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
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: SPINAL/EPIDURAL HEMATOMAS
. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection |
|---|---|
| Route | Subcutaneous |
| Prescription products | 9 in the FDA NDC Directory |
| Brand names | Fragmin |
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.
- Pfizer Laboratories Div Pfizer Inc9 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020287 FRAGMIN | Pfizer | December 22, 1994 | 46, latest October 24, 2024 2024: Labeling · 2024: Efficacy · 2020: 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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Fragmin, Pfizer Laboratories Div Pfizer Inc, effective September 30, 2025; 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 →