NDC 68382-619 Colesevelam

Colesevelam

NDC Product Code 68382-619

NDC 68382-619-10

Package Description: 1000 TABLET, FILM COATED in 1 BOTTLE

NDC 68382-619-28

Package Description: 180 TABLET, FILM COATED in 1 BOTTLE

NDC 68382-619-77

Package Description: 10 BLISTER PACK in 1 CARTON > 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-619-30)

NDC Product Information

Colesevelam with NDC 68382-619 is a a human prescription drug product labeled by Zydus Pharmaceuticals (usa) Inc.. The generic name of Colesevelam is colesevelam. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Zydus Pharmaceuticals (usa) Inc.

Dosage Form: Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.

Product Type: Human Prescription Drug 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.

Colesevelam Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • COLESEVELAM HYDROCHLORIDE 625 mg/1

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.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Bile Acid Sequestrant - [EPC] (Established Pharmacologic Class)
  • Bile-acid Binding Activity - [MoA] (Mechanism of Action)

Product Labeler Information

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

Labeler Name: Zydus Pharmaceuticals (usa) Inc.
Labeler Code: 68382
FDA Application Number: ANDA207765 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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. 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.

Start Marketing Date: 10-11-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

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Information for Patients

Colesevelam

Colesevelam is pronounced as (koh le sev' e lam)

Why is colesevelam medication prescribed?
Colesevelam is used in adults along with diet, weight loss, and exercise to reduce the amount of cholesterol and certain fatty substances in the blood alone or in combina...
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