NDC product

FORMOTEROL FUMARATE

NDC 0378-1631 · Mylan Pharmaceuticals Inc.

Key facts

Product NDC 0378-1631
Proprietary name FORMOTEROL FUMARATE
Nonproprietary name formoterol fumarate dihydrate
Substances FORMOTEROL FUMARATE
Dosage form SOLUTION
Route RESPIRATORY (INHALATION)
Labeler Mylan Pharmaceuticals Inc.
Product type HUMAN PRESCRIPTION DRUG
Marketing category NDA AUTHORIZED GENERIC
Application number NDA022007
Pharmacologic classes Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
Marketing start Jun 22, 2021
Listing certified through Dec 31, 2027

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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