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
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

enoxaparin sodium 300 mg/3mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-426
Product ID 71288-426_a4691de7-7504-48e7-ae54-a5441d5a002d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214856
Listing Expiration 2026-12-31
Marketing Start 2022-06-14

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 71288426
Hyphenated Format 71288-426

Supplemental Identifiers

RxCUI
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 ANDA214856 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 300 mg/3mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (71288-426-03) / 3 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

71288-426-03 1 VIAL, MULTI-DOSE in 1 CARTON (71288-426-03) / 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": "a4691de7-7504-48e7-ae54-a5441d5a002d", "openfda": {"unii": ["8NZ41MIK1O"], "rxcui": ["854255"], "spl_set_id": ["7d38c307-767f-4c38-ac0e-b8bb62782602"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (71288-426-03)  / 3 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "71288-426-03", "marketing_start_date": "20220614"}], "brand_name": "Enoxaparin Sodium", "product_id": "71288-426_a4691de7-7504-48e7-ae54-a5441d5a002d", "dosage_form": "INJECTION", "pharm_class": ["Heparin", "Low-Molecular-Weight [CS]", "Low Molecular Weight Heparin [EPC]"], "product_ndc": "71288-426", "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": "300 mg/3mL"}], "application_number": "ANDA214856", "marketing_category": "ANDA", "marketing_start_date": "20220614", "listing_expiration_date": "20261231"}