enoxaparin sodium

Generic: enoxaparin sodium

Labeler: sanofi-aventis u.s. llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name enoxaparin sodium
Generic Name enoxaparin sodium
Labeler sanofi-aventis u.s. llc
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

enoxaparin sodium 300 mg/3mL

Manufacturer
Sanofi-Aventis U.S. LLC

Identifiers & Regulatory

Product NDC 0955-1016
Product ID 0955-1016_48bacfb7-7152-45b1-a188-59c4a205f5b0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020164
Listing Expiration 2027-12-31
Marketing Start 2011-10-03

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 09551016
Hyphenated Format 0955-1016

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 NDA020164 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 300 mg/3mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (0955-1016-01) / 3 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

0955-1016-01 1 VIAL, MULTI-DOSE in 1 CARTON (0955-1016-01) / 3 mL in 1 VIAL, MULTI-DOSE

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": ["SUBCUTANEOUS"], "spl_id": "48bacfb7-7152-45b1-a188-59c4a205f5b0", "openfda": {"unii": ["8NZ41MIK1O"], "rxcui": ["854228", "854235", "854238", "854241", "854245", "854248", "854252", "854255"], "spl_set_id": ["20635579-c92d-4f6c-a332-1096d51002f2"], "manufacturer_name": ["Sanofi-Aventis U.S. LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (0955-1016-01)  / 3 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "0955-1016-01", "marketing_start_date": "20111003"}], "brand_name": "Enoxaparin sodium", "product_id": "0955-1016_48bacfb7-7152-45b1-a188-59c4a205f5b0", "dosage_form": "INJECTION", "pharm_class": ["Heparin", "Low-Molecular-Weight [CS]", "Low Molecular Weight Heparin [EPC]"], "product_ndc": "0955-1016", "generic_name": "enoxaparin sodium", "labeler_name": "Sanofi-Aventis U.S. LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Enoxaparin sodium", "active_ingredients": [{"name": "ENOXAPARIN SODIUM", "strength": "300 mg/3mL"}], "application_number": "NDA020164", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20111003", "listing_expiration_date": "20271231"}