NDC product

cevimeline hydrochloride

NDC 0054-0893 · Hikma Pharmaceuticals USA Inc.

Key facts

Product NDC 0054-0893
Proprietary name cevimeline hydrochloride
Nonproprietary name cevimeline hydrochloride
Substances CEVIMELINE HYDROCHLORIDE
Dosage form CAPSULE
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA091591
Pharmacologic classes Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]
Marketing start Oct 5, 2026
Listing certified through Dec 31, 2027

At a glance

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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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