NDC product

Quetiapine Fumarate ER

NDC 72189-519 · Direct_Rx

Key facts

Product NDC 72189-519
Proprietary name Quetiapine Fumarate ER
Nonproprietary name Quetiapine Fumarate ER
Substances QUETIAPINE FUMARATE
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Route ORAL
Labeler Direct_Rx
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA209635
Pharmacologic classes Atypical Antipsychotic [EPC]
Marketing start Nov 1, 2023
Listing certified through Dec 31, 2026

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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