Active ingredient
Dalteparin
9 finished FDA listings contain Dalteparin as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- DALTEPARIN SODIUM
- Dosage forms
- Injection
- Routes
- Subcutaneous
- Manufacturers / labelers
- 1
- Strengths listed
- 10000 [iu]/ml · 12500 [iu]/.5ml · 15000 [iu]/.6ml · 18000 [iu]/.72ml · 2500 [iu]/.2ml · 2500 [iu]/ml · 25000 [iu]/ml · 5000 [iu]/.2ml · 7500 [iu]/.3ml
- Brand names in FDA listings
- Fragmin
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 67109
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 020287 | PFIZER | 1994-12-22 | 9 |
Official labeling on DailyMed
- FRAGMIN (DALTEPARIN SODIUM) INJECTION [PFIZER LABORATORIES DIV PFIZER INC] · version 27 · 2025-10-02
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.