0406-1183 NDC - QUETIAPINE FUMARATE ()

Drug Information

Product NDC: 0406-1183

Proprietary Name: Quetiapine Fumarate

Non Proprietary Name:

Active Ingredient(s):


Administration Route(s):

Dosage Form(s):

Labeler Information

Labeler Name: SpecGx LLC
Product Type:
FDA Application Number:
Marketing Category:
Start Marketing Date:5/15/2017

Package Information

No. Package Code Package Description Billing Unit
10406-1183-6060 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-1183-60)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0406-1183The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEQuetiapine FumarateThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIXExtended-ReleaseA suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
START MARKETING DATE5/15/2017This is the date that the labeler indicates was the start of its marketing of the drug product.
LABELER NAMESpecGx LLCName of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 2/1/2023