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NDC 70100-424 Indocyanine Green

Indocyanine Green And Water Kit - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 70100-424?
  4. Indocyanine Green Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes

Product Information

NDC Product Code:
70100-424
Proprietary Name:
Indocyanine Green
Non-Proprietary Name: [1]
Indocyanine Green And Water
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.
Labeler Name: [5]
Renew Pharmaceuticals Limited
Labeler Code:
70100
Product Label ID:
a6f24787-c243-445a-9c55-7c7479b292d9
FDA Application Number: [6]
ANDA040811
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
01-01-2008
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
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Product Details

What is NDC 70100-424?

The NDC code 70100-424 is assigned by the FDA to the product Indocyanine Green which is a human prescription drug product labeled by Renew Pharmaceuticals Limited. The generic name of Indocyanine Green is indocyanine green and water. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 70100-424-02 6 package in 1 carton / 1 kit in 1 package * 1 injection, powder, lyophilized, for solution in 1 vial * 10 ml in 1 vial, plastic (0409-4887-17). 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 Indocyanine Green?

Indocyanine Green for injection is indicated:

Which are Indocyanine Green UNII Codes?

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

Which are Indocyanine Green 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:

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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.

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

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[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".