NDC product

Colesevelam Hydrochloride

NDC 33342-197 · Macleods Pharmaceuticals Limited

Key facts

Product NDC 33342-197
Proprietary name Colesevelam Hydrochloride
Nonproprietary name Colesevelam Hydrochloride
Substances COLESEVELAM HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA204893
Pharmacologic classes Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]
Marketing start Apr 18, 2025
Listing certified through Dec 31, 2026

At a glance

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About National Drug Codes (NDC)

The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.

Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date:

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