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
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

enoxaparin sodium 300 mg/3mL

Manufacturer
Amphastar Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0548-5608
Product ID 0548-5608_2910408b-d506-4a3a-a2c8-64fc46ba0da0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208600
Listing Expiration 2026-12-31
Marketing Start 2019-11-11

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 05485608
Hyphenated Format 0548-5608

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 ANDA208600 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 300 mg/3mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (0548-5608-00) / 3 mL in 1 VIAL
source: ndc

Packages (1)

0548-5608-00 1 VIAL in 1 CARTON (0548-5608-00) / 3 mL in 1 VIAL

Ingredients (1)

enoxaparin sodium (300 mg/3mL)

Linked Drug Pages (1)

Enoxaparin Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS", "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": "1 VIAL in 1 CARTON (0548-5608-00)  / 3 mL in 1 VIAL", "package_ndc": "0548-5608-00", "marketing_start_date": "20191111"}], "brand_name": "Enoxaparin Sodium", "product_id": "0548-5608_2910408b-d506-4a3a-a2c8-64fc46ba0da0", "dosage_form": "INJECTION", "pharm_class": ["Heparin", "Low-Molecular-Weight [CS]", "Low Molecular Weight Heparin [EPC]"], "product_ndc": "0548-5608", "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": "300 mg/3mL"}], "application_number": "ANDA208600", "marketing_category": "ANDA", "marketing_start_date": "20191111", "listing_expiration_date": "20261231"}