enoxaparin sodium

Generic: enoxaparin sodium

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

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

enoxaparin sodium 300 mg/3mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-539
Product ID 63323-539_a12d41f8-475d-4932-9aa0-73180eb1fd60
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020164
Listing Expiration 2027-12-31
Marketing Start 2019-06-18

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 63323539
Hyphenated Format 63323-539

Supplemental Identifiers

RxCUI
854228 854235 854238 854241 854245 854248 854252 854255
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 NDA020164 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 300 mg/3mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (63323-539-13) / 3 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

63323-539-13 1 VIAL, MULTI-DOSE in 1 CARTON (63323-539-13) / 3 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

enoxaparin sodium (300 mg/3mL)

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": ["INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "a12d41f8-475d-4932-9aa0-73180eb1fd60", "openfda": {"unii": ["8NZ41MIK1O"], "rxcui": ["854228", "854235", "854238", "854241", "854245", "854248", "854252", "854255"], "spl_set_id": ["066f27ec-352c-4051-ba29-248e292690db"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (63323-539-13)  / 3 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "63323-539-13", "marketing_start_date": "20190618"}], "brand_name": "Enoxaparin Sodium", "product_id": "63323-539_a12d41f8-475d-4932-9aa0-73180eb1fd60", "dosage_form": "INJECTION", "pharm_class": ["Heparin", "Low-Molecular-Weight [CS]", "Low Molecular Weight Heparin [EPC]"], "product_ndc": "63323-539", "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": "300 mg/3mL"}], "application_number": "NDA020164", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20190618", "listing_expiration_date": "20271231"}