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  4. NDC Product Code: 76420-532 Enoxiluv Kit

NDC 76420-532 Enoxiluv Kit

Enoxaparin Sodium,Isopropyl Alcohol Kit Subcutaneous; Topical - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 76420-532?
  5. Enoxiluv Kit Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
76420-532
Proprietary Name:
Enoxiluv Kit
Non-Proprietary Name: [1]
Enoxaparin Sodium, Isopropyl Alcohol
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Administration Route(s): [4]
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
    • Labeler Name: [5]
    Asclemed Usa, Inc.
    Labeler Code:
    76420
    Product Label ID:
    e8855fae-f70d-4099-969e-a1d9f2929259
    Marketing Category: [8]
    UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
    Start Marketing Date: [9]
    02-08-2023
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325 - WHITE TO OFF WHITE)

    Code Structure Chart

    Product Details

    What is NDC 76420-532?

    The NDC code 76420-532 is assigned by the FDA to the product Enoxiluv Kit which is a human prescription drug product labeled by Asclemed Usa, Inc.. The generic name of Enoxiluv Kit is enoxaparin sodium, isopropyl alcohol. The product's dosage form is kit and is administered via subcutaneous; topical form. The product is distributed in a single package with assigned NDC code 76420-532-01 1 kit in 1 carton * 10 syringe in 1 carton (0781-3246-64) / .4 ml in 1 syringe * 5 ml in 1 pouch. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Enoxiluv Kit?

    Enoxaparin sodium injection is contraindicated in patients with:Active major bleeding. History of immune-mediated heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies [see Warnings and Precautions ( 5.4)] . Known hypersensitivity to enoxaparin sodium ( e.g., pruritus, urticaria, anaphylactic/anaphylactoid reactions) [see Adverse Reactions (6.2)] . Known hypersensitivity to heparin or pork products. Known hypersensitivity to benzyl alcohol (which is in only the multiple-dose formulation of enoxaparin sodium injection) [see Warnings and Precautions (5.8)].

    Which are Enoxiluv Kit UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Enoxiluv Kit Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Enoxiluv Kit?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".