NDC product

HYDROXYZINE HYDROCHLORIDE

NDC 16571-113 · Rising Pharma Holdings, Inc.

Key facts

Product NDC 16571-113
Proprietary name HYDROXYZINE HYDROCHLORIDE
Nonproprietary name hydroxyzine hydrochloride
Substances HYDROXYZINE DIHYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA217652
Pharmacologic classes Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
Marketing start Aug 22, 2023
Listing certified through Dec 31, 2026

At a glance

  • 1–9 Package NDCs

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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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