enoxaparin sodium

Generic: enoxaparin sodium

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name enoxaparin sodium
Generic Name enoxaparin sodium
Labeler fresenius kabi usa, llc
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

enoxaparin sodium 40 mg/.4mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-535
Product ID 63323-535_53e20cb1-9e79-4c45-a5a7-62c3904df818
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020164
Listing Expiration 2027-12-31
Marketing Start 2019-06-18

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 63323535
Hyphenated Format 63323-535

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
  • 40 mg/.4mL
source: ndc
Packaging
  • 10 CELLO PACK in 1 CARTON (63323-535-87) / 1 SYRINGE in 1 CELLO PACK (63323-535-01) / .4 mL in 1 SYRINGE
source: ndc

Packages (1)

63323-535-87 10 CELLO PACK in 1 CARTON (63323-535-87) / 1 SYRINGE in 1 CELLO PACK (63323-535-01) / .4 mL in 1 SYRINGE

Ingredients (1)

enoxaparin sodium (40 mg/.4mL)

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": "53e20cb1-9e79-4c45-a5a7-62c3904df818", "openfda": {"unii": ["8NZ41MIK1O"], "rxcui": ["854228", "854235", "854238", "854241", "854245", "854248", "854252", "854255"], "spl_set_id": ["21b095d1-5ade-43e9-9114-30fbfb2331c9"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 CELLO PACK in 1 CARTON (63323-535-87)  / 1 SYRINGE in 1 CELLO PACK (63323-535-01)  / .4 mL in 1 SYRINGE", "package_ndc": "63323-535-87", "marketing_start_date": "20190618"}], "brand_name": "Enoxaparin Sodium", "product_id": "63323-535_53e20cb1-9e79-4c45-a5a7-62c3904df818", "dosage_form": "INJECTION", "pharm_class": ["Heparin", "Low-Molecular-Weight [CS]", "Low Molecular Weight Heparin [EPC]"], "product_ndc": "63323-535", "generic_name": "enoxaparin sodium", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Enoxaparin Sodium", "active_ingredients": [{"name": "ENOXAPARIN SODIUM", "strength": "40 mg/.4mL"}], "application_number": "NDA020164", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20190618", "listing_expiration_date": "20271231"}