Enoxiluv Kit
NDC 76420-532

View dosage, usage, ingredients, routes, and UNII mappings.
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

Product Information

Enoxiluv Kit (enoxaparin sodium, isopropyl alcohol) is a UNAPPROVED DRUG OTHER-approved product labeled by Asclemed Usa, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a white kit for subcutaneous; topical administration. This product entry covers the primary NDC 76420-532 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

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
Code Navigator:

Clinical Specifications

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 & Regulatory Data

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.

Marketing Timeline

Start Marketing Date: [9]
02-08-2023
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

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. It is commonly known by its generic name, enoxaparin sodium, isopropyl alcohol. This pharmaceutical product is labeled by Asclemed Usa, Inc. and is currently categorized as listed product. The medication is a kit administered via subcutaneous; topical route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 76420-532-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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 the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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:

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Product & Regulatory Definitions
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".