enoxaparin sodium

Generic: enoxaparin sodium

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name enoxaparin sodium
Generic Name enoxaparin sodium
Labeler gland pharma limited
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

enoxaparin sodium 120 mg/.8mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-639
Product ID 68083-639_24d882c6-ad8c-488a-a3ab-810f5feb4025
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078990
Listing Expiration 2027-12-31
Marketing Start 2023-07-11

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 68083639
Hyphenated Format 68083-639

Supplemental Identifiers

RxCUI
854228 854235 854238 854241 854245 854248 854252
UPC
0368083637101 0368083638108 0368083640101 0368083639105 0368083634100
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
  • 120 mg/.8mL
source: ndc
Packaging
  • 10 SYRINGE in 1 CARTON (68083-639-10) / .8 mL in 1 SYRINGE
source: ndc

Packages (1)

68083-639-10 10 SYRINGE in 1 CARTON (68083-639-10) / .8 mL in 1 SYRINGE

Ingredients (1)

enoxaparin sodium (120 mg/.8mL)

Linked Drug Pages (1)

ENOXAPARIN SODIUM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "24d882c6-ad8c-488a-a3ab-810f5feb4025", "openfda": {"upc": ["0368083637101", "0368083638108", "0368083640101", "0368083639105", "0368083634100"], "unii": ["8NZ41MIK1O"], "rxcui": ["854228", "854235", "854238", "854241", "854245", "854248", "854252"], "spl_set_id": ["65025e0d-eb54-4c4e-bd14-f294ce038902"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 SYRINGE in 1 CARTON (68083-639-10)  / .8 mL in 1 SYRINGE", "package_ndc": "68083-639-10", "marketing_start_date": "20230711"}], "brand_name": "ENOXAPARIN SODIUM", "product_id": "68083-639_24d882c6-ad8c-488a-a3ab-810f5feb4025", "dosage_form": "INJECTION", "pharm_class": ["Heparin", "Low-Molecular-Weight [CS]", "Low Molecular Weight Heparin [EPC]"], "product_ndc": "68083-639", "generic_name": "ENOXAPARIN SODIUM", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ENOXAPARIN SODIUM", "active_ingredients": [{"name": "ENOXAPARIN SODIUM", "strength": "120 mg/.8mL"}], "application_number": "ANDA078990", "marketing_category": "ANDA", "marketing_start_date": "20230711", "listing_expiration_date": "20271231"}