enoxaparin sodium

Generic: enoxaparin sodium

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name enoxaparin sodium
Generic Name enoxaparin sodium
Labeler fresenius kabi usa, llc
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

enoxaparin sodium 100 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-586
Product ID 63323-586_db998293-f7be-4d13-b2bf-bd8ec2acdc89
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078990
Listing Expiration 2026-12-31
Marketing Start 2019-04-23

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 63323586
Hyphenated Format 63323-586

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 ANDA078990 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (63323-586-96) / 1 SYRINGE in 1 BLISTER PACK (63323-586-21) / 1 mL in 1 SYRINGE
source: ndc

Packages (1)

63323-586-96 10 BLISTER PACK in 1 CARTON (63323-586-96) / 1 SYRINGE in 1 BLISTER PACK (63323-586-21) / 1 mL in 1 SYRINGE

Ingredients (1)

enoxaparin sodium (100 mg/mL)

Linked Drug Pages (2)

Enoxaparin Sodium ndc-match (0.9) Enoxaparin Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "db998293-f7be-4d13-b2bf-bd8ec2acdc89", "openfda": {"unii": ["8NZ41MIK1O"], "rxcui": ["854228", "854235", "854238", "854241", "854245", "854248", "854252"], "spl_set_id": ["a694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (63323-586-96)  / 1 SYRINGE in 1 BLISTER PACK (63323-586-21)  / 1 mL in 1 SYRINGE", "package_ndc": "63323-586-96", "marketing_start_date": "20190423"}], "brand_name": "Enoxaparin Sodium", "product_id": "63323-586_db998293-f7be-4d13-b2bf-bd8ec2acdc89", "dosage_form": "INJECTION", "pharm_class": ["Heparin", "Low-Molecular-Weight [CS]", "Low Molecular Weight Heparin [EPC]"], "product_ndc": "63323-586", "generic_name": "Enoxaparin Sodium", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Enoxaparin Sodium", "active_ingredients": [{"name": "ENOXAPARIN SODIUM", "strength": "100 mg/mL"}], "application_number": "ANDA078990", "marketing_category": "ANDA", "marketing_start_date": "20190423", "listing_expiration_date": "20261231"}