enoxaparin sodium

Generic: enoxaparin sodium

Labeler: meitheal pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name enoxaparin sodium
Generic Name enoxaparin sodium
Labeler meitheal pharmaceuticals inc.
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

enoxaparin sodium 100 mg/mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-434
Product ID 71288-434_a3c72056-bfa7-404e-961d-79247263adff
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206834
Listing Expiration 2026-12-31
Marketing Start 2019-12-01

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 71288434
Hyphenated Format 71288-434

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 ANDA206834 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 10 SYRINGE in 1 CARTON (71288-434-85) / .6 mL in 1 SYRINGE (71288-434-84)
source: ndc

Packages (1)

71288-434-85 10 SYRINGE in 1 CARTON (71288-434-85) / .6 mL in 1 SYRINGE (71288-434-84)

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": "a3c72056-bfa7-404e-961d-79247263adff", "openfda": {"unii": ["8NZ41MIK1O"], "rxcui": ["854228", "854235", "854238", "854241", "854245", "854248", "854252"], "spl_set_id": ["adbba7bb-fa72-4cec-aa69-13965591a45d"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 SYRINGE in 1 CARTON (71288-434-85)  / .6 mL in 1 SYRINGE (71288-434-84)", "package_ndc": "71288-434-85", "marketing_start_date": "20191201"}], "brand_name": "Enoxaparin Sodium", "product_id": "71288-434_a3c72056-bfa7-404e-961d-79247263adff", "dosage_form": "INJECTION", "pharm_class": ["Heparin", "Low-Molecular-Weight [CS]", "Low Molecular Weight Heparin [EPC]"], "product_ndc": "71288-434", "generic_name": "Enoxaparin Sodium", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Enoxaparin Sodium", "active_ingredients": [{"name": "ENOXAPARIN SODIUM", "strength": "100 mg/mL"}], "application_number": "ANDA206834", "marketing_category": "ANDA", "marketing_start_date": "20191201", "listing_expiration_date": "20261231"}