NDC product

GUAIFENESIN AND DEXTROMETHORPHAN HBR

NDC 76162-032 · TOPCO ASSOCIATES LLC

Key facts

Product NDC 76162-032
Proprietary name GUAIFENESIN AND DEXTROMETHORPHAN HBR
Nonproprietary name GUAIFENESIN AND DEXTROMETHORPHAN HBR
Substances GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler TOPCO ASSOCIATES LLC
Product type HUMAN OTC DRUG
Marketing category ANDA
Application number ANDA206941
Pharmacologic classes Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC] and 1 more
Marketing start Apr 23, 2026
Listing certified through Dec 31, 2027

At a glance

  • 1–9 Package NDCs

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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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