NDC 0009-0260 Colestid
Colestipol Hydrochloride Granule, For Suspension Oral

Table of Contents

    1. Product Information
    2. Product Packages
    3. What is NDC 0009-0260?
    4. Colestid Uses
    5. Active Ingredients
    6. Active Ingredients UNII Codes
    7. Inactive Ingredients UNII Codes
    8. NDC to RxNorm Crosswalk
    9. Pharmacologic Classes

Product Information

NDC Product Code0009-0260
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		Colestid
Non-Proprietary Name 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.		Colestipol Hydrochloride
Substance Name What is the Substance Name?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.		Colestipol Hydrochloride
Product Type 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.		Human Prescription Drug
NDC Directory StatusACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage FormGranule, For Suspension - A small medicinal particle or grain made available in its more stable dry form, to be reconstituted with solvent just before dispensing to form a suspension; the granules are so prepared to contain not only the medicinal agent, but the colorants, flavorants, and any other desired pharmaceutic ingredient.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Pharmacia & Upjohn Company Llc
Labeler Code0009
SPL SET ID:21b37725-fc0c-4365-a7dc-1a473d42502d
FDA Application Number 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.		NDA017563
Marketing Category 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.		NDA - A product marketed under an approved New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		04-04-1977
Listing Expiration Date 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.		12-31-2023
Exclude Flag 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". 		N
NDC Code Structure

Product Packages

NDC Code 0009-0260-01

Package Description: 30 PACKET in 1 CARTON / 5 g in 1 PACKET

Price per Unit: $6.59199 per EA

NDC Code 0009-0260-02

Package Description: 1 BOTTLE in 1 CARTON / 500 g in 1 BOTTLE

NDC Code 0009-0260-04

Package Description: 90 PACKET in 1 CARTON / 5 g in 1 PACKET

Price per Unit: $6.59199 per EA

NDC Code 0009-0260-17

Package Description: 1 BOTTLE in 1 CARTON / 300 g in 1 BOTTLE

Product Details

What is NDC 0009-0260?

The NDC code 0009-0260 is assigned by the FDA to the product Colestid which is a human prescription drug product labeled by Pharmacia & Upjohn Company Llc. The generic name of Colestid is colestipol hydrochloride. The product's dosage form is granule, for suspension and is administered via oral form. The product is distributed in 4 packages with assigned NDC codes 0009-0260-01 30 packet in 1 carton / 5 g in 1 packet, 0009-0260-02 1 bottle in 1 carton / 500 g in 1 bottle, 0009-0260-04 90 packet in 1 carton / 5 g in 1 packet, 0009-0260-17 1 bottle in 1 carton / 300 g in 1 bottle. 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 Colestid?

Colestipol is used along with a proper diet to lower cholesterol in the blood. Lowering cholesterol helps decrease the risk for strokes and heart attacks. In addition to a proper diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help this medication work better include exercising, losing weight if overweight, and stopping smoking. Consult your doctor for more details. This medication is known as a bile acid-binding resin. It works by removing bile acid from the body. In people with high cholesterol, this causes the liver to make more bile acid by using cholesterol in the blood. This helps to lower the cholesterol levels.

What are Colestid Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • COLESTIPOL HYDROCHLORIDE 5 g/5g - Highly crosslinked and insoluble basic anion exchange resin used as anticholesteremic. It may also may reduce triglyceride levels.

Which are Colestid UNII Codes?

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

Which are Colestid 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 Colestid?

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:
  • RxCUI: 1048450 - colestipol HCl 5 GM Granules For Oral Suspension
  • RxCUI: 1048450 - colestipol hydrochloride 5000 MG Granules for Oral Suspension
  • RxCUI: 1048450 - colestipol hydrochloride 5 GM Granules For Oral Suspension
  • RxCUI: 1048452 - Colestid 5 GM Granules For Oral Suspension
  • RxCUI: 1048452 - colestipol hydrochloride 5000 MG Granules for Oral Suspension [Colestid]

Which are the Pharmacologic Classes for Colestid?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Product Label

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