NDC product

Dextromethorphan Hydrobromide

NDC 35916-0461 · Softgel Healthcare Pvt Ltd

Key facts

Product NDC 35916-0461
Proprietary name Dextromethorphan Hydrobromide
Nonproprietary name Dextromethorphan Hydrobromide
Substances DEXTROMETHORPHAN HYDROBROMIDE
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Softgel Healthcare Pvt Ltd
Product type HUMAN OTC DRUG
Marketing category OTC MONOGRAPH DRUG
Application number M012
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 Sep 11, 2024
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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