NDC product

Loperamide Hydrochloride 2mg

NDC 25000-001 · MARKSANS PHARMA LIMITED

Key facts

Product NDC 25000-001
Proprietary name Loperamide Hydrochloride 2mg
Nonproprietary name Loperamide Hydrochloride Tablets USP, 2mg
Substances LOPERAMIDE HYDROCHLORIDE
Dosage form TABLET
Route ORAL
Labeler MARKSANS PHARMA LIMITED
Product type HUMAN OTC DRUG
Marketing category ANDA
Application number ANDA220153
Pharmacologic classes Opioid Agonist [EPC], Opioid Agonists [MoA]
Marketing start Nov 19, 2025
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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