NDC product

Topcare Mucus DM

NDC 36800-219 · Topco Associates LLC

Key facts

Product NDC 36800-219
Proprietary name Topcare Mucus DM
Nonproprietary name dextromethorphan hydrobromide, guaifenesin
Substances DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler Topco Associates LLC
Product type HUMAN OTC DRUG
Marketing category ANDA
Application number ANDA207602
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 Jul 10, 2019
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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