enoxaparin sodium

Generic: enoxaparin sodium

Labeler: italfarmaco spa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name enoxaparin sodium
Generic Name enoxaparin sodium
Labeler italfarmaco spa
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

enoxaparin sodium 40 mg/.4mL

Manufacturer
Italfarmaco SpA

Identifiers & Regulatory

Product NDC 11797-758
Product ID 11797-758_3102514e-1702-4b7d-9d26-60e98488ffc3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076726
Listing Expiration 2026-12-31
Marketing Start 2021-04-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 11797758
Hyphenated Format 11797-758

Supplemental Identifiers

RxCUI
854228 854235 854238 854241 854245 854248 854252
UNII
8NZ41MIK1O

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 enoxaparin sodium (source: ndc)
Generic Name enoxaparin sodium (source: ndc)
Application Number ANDA076726 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 40 mg/.4mL
source: ndc
Packaging
  • 10 SYRINGE in 1 CARTON (11797-758-06) / .4 mL in 1 SYRINGE (11797-758-02)
source: ndc

Packages (1)

11797-758-06 10 SYRINGE in 1 CARTON (11797-758-06) / .4 mL in 1 SYRINGE (11797-758-02)

Ingredients (1)

enoxaparin sodium (40 mg/.4mL)

Linked Drug Pages (1)

Enoxaparin Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "3102514e-1702-4b7d-9d26-60e98488ffc3", "openfda": {"unii": ["8NZ41MIK1O"], "rxcui": ["854228", "854235", "854238", "854241", "854245", "854248", "854252"], "spl_set_id": ["b4d9e4d4-4fdb-48d6-a169-7bc5eebc51e9"], "manufacturer_name": ["Italfarmaco SpA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 SYRINGE in 1 CARTON (11797-758-06)  / .4 mL in 1 SYRINGE (11797-758-02)", "package_ndc": "11797-758-06", "marketing_start_date": "20210401"}], "brand_name": "Enoxaparin Sodium", "product_id": "11797-758_3102514e-1702-4b7d-9d26-60e98488ffc3", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Heparin", "Low-Molecular-Weight [CS]", "Low Molecular Weight Heparin [EPC]"], "product_ndc": "11797-758", "generic_name": "Enoxaparin Sodium", "labeler_name": "Italfarmaco SpA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Enoxaparin Sodium", "active_ingredients": [{"name": "ENOXAPARIN SODIUM", "strength": "40 mg/.4mL"}], "application_number": "ANDA076726", "marketing_category": "ANDA", "marketing_start_date": "20210401", "listing_expiration_date": "20261231"}