NDC product

Acetylcysteine

NDC 0517-7604 · American Regent, Inc.

Key facts

Product NDC 0517-7604
Proprietary name Acetylcysteine
Nonproprietary name acetylcysteine
Substances ACETYLCYSTEINE
Dosage form INHALANT
Route RESPIRATORY (INHALATION)
Labeler American Regent, Inc.
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA072547
Pharmacologic classes Antidote [EPC], Antidote for Acetaminophen Overdose [EPC], Decreased Respiratory Secretion Viscosity [PE], Increased Glutathione Concentration [PE], Mucolytic [EPC], Reduction Activity [MoA]
Marketing start Oct 1, 1995
Listing certified through Dec 31, 2026

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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