fragmin

Generic: dalteparin sodium

Labeler: pfizer laboratories div pfizer inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name fragmin
Generic Name dalteparin sodium
Labeler pfizer laboratories div pfizer inc
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

dalteparin sodium 2500 [iU]/.2mL

Manufacturer
Pfizer Laboratories Div Pfizer Inc

Identifiers & Regulatory

Product NDC 0069-0195
Product ID 0069-0195_af340f13-7954-4974-845d-ae55e0b56512
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020287
Listing Expiration 2026-12-31
Marketing Start 2015-04-01

Pharmacologic Class

Classes
anti-coagulant [epc] heparin low-molecular-weight [cs] low molecular weight heparin [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00690195
Hyphenated Format 0069-0195

Supplemental Identifiers

RxCUI
978725 978727 978733 978735 978736 978737 978740 978741 978744 978745 978746 978747 978755 978757 978777 978778 2618839 2618842
UNII
12M44VTJ7B

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name fragmin (source: ndc)
Generic Name dalteparin sodium (source: ndc)
Application Number NDA020287 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 2500 [iU]/.2mL
source: ndc
Packaging
  • 10 SYRINGE in 1 CARTON (0069-0195-02) / .2 mL in 1 SYRINGE (0069-0195-01)
source: ndc

Packages (1)

0069-0195-02 10 SYRINGE in 1 CARTON (0069-0195-02) / .2 mL in 1 SYRINGE (0069-0195-01)

Ingredients (1)

dalteparin sodium (2500 [iU]/.2mL)

Linked Drug Pages (1)

Fragmin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "af340f13-7954-4974-845d-ae55e0b56512", "openfda": {"unii": ["12M44VTJ7B"], "rxcui": ["978725", "978727", "978733", "978735", "978736", "978737", "978740", "978741", "978744", "978745", "978746", "978747", "978755", "978757", "978777", "978778", "2618839", "2618842"], "spl_set_id": ["23527b8b-9b28-4e6d-9751-33b143975ac7"], "manufacturer_name": ["Pfizer Laboratories Div Pfizer Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 SYRINGE in 1 CARTON (0069-0195-02)  / .2 mL in 1 SYRINGE (0069-0195-01)", "package_ndc": "0069-0195-02", "marketing_start_date": "20150401"}], "brand_name": "Fragmin", "product_id": "0069-0195_af340f13-7954-4974-845d-ae55e0b56512", "dosage_form": "INJECTION", "pharm_class": ["Anti-coagulant [EPC]", "Heparin", "Low-Molecular-Weight [CS]", "Low Molecular Weight Heparin [EPC]"], "product_ndc": "0069-0195", "generic_name": "Dalteparin Sodium", "labeler_name": "Pfizer Laboratories Div Pfizer Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fragmin", "active_ingredients": [{"name": "DALTEPARIN SODIUM", "strength": "2500 [iU]/.2mL"}], "application_number": "NDA020287", "marketing_category": "NDA", "marketing_start_date": "20150401", "listing_expiration_date": "20261231"}