NDC 35781-0400 Colcigel

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
35781-0400
Proprietary Name:
Colcigel
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Gensco Laboratories, Llc
Labeler Code:
35781
Start Marketing Date: [9]
05-01-2015
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Packages

NDC Code 35781-0400-2

Package Description: 1 BOTTLE, DISPENSING in 1 CARTON / 15 mL in 1 BOTTLE, DISPENSING

NDC Code 35781-0400-4

Package Description: 2 BOTTLE, DISPENSING in 1 PACKAGE / 30 mL in 1 BOTTLE, DISPENSING

Product Details

What is NDC 35781-0400?

The NDC code 35781-0400 is assigned by the FDA to the product Colcigel which is product labeled by Gensco Laboratories, Llc. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 35781-0400-2 1 bottle, dispensing in 1 carton / 15 ml in 1 bottle, dispensing, 35781-0400-4 2 bottle, dispensing in 1 package / 30 ml in 1 bottle, dispensing. 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 Colcigel?

ColciGel® transdermal gel is indicated for prophylaxis and the treatment of acute gout flares.Treatment of Gout Flares:ColciGel® gel is indicated for treatment of acute gout flares when used at the first sign of a flare.Prophylaxis of Gout Flares:ColciGel® is indicated for prophylaxis of gout flares.

Which are Colcigel UNII Codes?

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

Which are Colcigel 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:

* Please review the disclaimer below.

Product Footnotes

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

[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".