NDC product

Quetiapine Fumarate

NDC 34908-638 · Novast Laboratories, Ltd.

Key facts

Product NDC 34908-638
Proprietary name Quetiapine Fumarate
Nonproprietary name quetiapine fumarate
Substances QUETIAPINE FUMARATE
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler Novast Laboratories, Ltd.
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA208947
Pharmacologic classes Atypical Antipsychotic [EPC]
Marketing start Aug 31, 2017
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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