NDC product

Cetirizine Hydrochloride

NDC 0378-3637 · Mylan Pharmaceuticals Inc.

Key facts

Product NDC 0378-3637
Proprietary name Cetirizine Hydrochloride
Nonproprietary name cetirizine hydrochloride
Substances CETIRIZINE HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Product type HUMAN OTC DRUG
Marketing category ANDA
Application number ANDA076677
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
Marketing start Dec 27, 2007
Listing certified through Dec 31, 2027

At a glance

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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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