NDC product

Dextromethorphan Polistirex Extended-Release

NDC 65162-700 · Amneal Pharmaceuticals LLC

Key facts

Product NDC 65162-700
Proprietary name Dextromethorphan Polistirex Extended-Release
Nonproprietary name Dextromethorphan Polistirex
Substances DEXTROMETHORPHAN HYDROBROMIDE
Dosage form SUSPENSION
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Product type HUMAN OTC DRUG
Marketing category ANDA
Application number ANDA203133
Pharmacologic classes Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
Marketing start Aug 1, 2017
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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