NDC product

varenicline

NDC 0904-7414 · Major Pharmaceuticals

Key facts

Product NDC 0904-7414
Proprietary name varenicline
Nonproprietary name varenicline tartrate
Substances VARENICLINE TARTRATE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Major Pharmaceuticals
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA214557
Pharmacologic classes Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]
Marketing start Dec 18, 2023
Listing certified through Dec 31, 2027

At a glance

  • 1–9 Package NDCs

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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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