enoxaparin sodium

Generic: enoxaparin sodium

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

Drug Facts

Product Profile

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

enoxaparin sodium 100 mg/mL

Manufacturer
Amphastar Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0548-5604
Product ID 0548-5604_2910408b-d506-4a3a-a2c8-64fc46ba0da0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076684
Listing Expiration 2026-12-31
Marketing Start 2011-09-19

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 05485604
Hyphenated Format 0548-5604

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 ANDA076684 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 10 SYRINGE in 1 CARTON (0548-5604-00) / .8 mL in 1 SYRINGE
source: ndc

Packages (1)

0548-5604-00 10 SYRINGE in 1 CARTON (0548-5604-00) / .8 mL in 1 SYRINGE

Ingredients (1)

enoxaparin sodium (100 mg/mL)

Linked Drug Pages (1)

Enoxaparin Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "2910408b-d506-4a3a-a2c8-64fc46ba0da0", "openfda": {"unii": ["8NZ41MIK1O"], "rxcui": ["854228", "854235", "854238", "854241", "854245", "854248", "854252", "854255"], "spl_set_id": ["3e6bf2b3-9339-4104-bda3-ad86a1949703"], "manufacturer_name": ["Amphastar Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 SYRINGE in 1 CARTON (0548-5604-00)  / .8 mL in 1 SYRINGE", "package_ndc": "0548-5604-00", "marketing_start_date": "20110919"}], "brand_name": "Enoxaparin Sodium", "product_id": "0548-5604_2910408b-d506-4a3a-a2c8-64fc46ba0da0", "dosage_form": "INJECTION", "pharm_class": ["Heparin", "Low-Molecular-Weight [CS]", "Low Molecular Weight Heparin [EPC]"], "product_ndc": "0548-5604", "generic_name": "Enoxaparin sodium", "labeler_name": "Amphastar Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Enoxaparin Sodium", "active_ingredients": [{"name": "ENOXAPARIN SODIUM", "strength": "100 mg/mL"}], "application_number": "ANDA076684", "marketing_category": "ANDA", "marketing_start_date": "20110919", "listing_expiration_date": "20261231"}