0054-0229 NDC - QUETIAPINE FUMARATE

Drug Information

Product NDC: 0054-0229

Proprietary Name: Quetiapine Fumarate

Non Proprietary Name: Quetiapine Fumarate

Active Ingredient(s):
  • 50 mg/1 QUETIAPINE FUMARATE


Administration Route(s): ORAL

Dosage Form(s): TABLET

Pharmacy Class(es):
  • Atypical Antipsychotic [EPC]

Labeler Information

Labeler Name: West-Ward Pharmaceuticals Corp
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA090749
Marketing Category: ANDA
Start Marketing Date:3/27/2012

Package Information

No. Package Code Package Description Billing Unit
10054-0229-2010 BLISTER PACK in 1 CARTON (0054-0229-20) > 10 TABLET in 1 BLISTER PACKEA
20054-0229-25100 TABLET in 1 BOTTLE (0054-0229-25)EA
30054-0229-311000 TABLET in 1 BOTTLE (0054-0229-31)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0054-0229The 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.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
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.
NON PROPRIETARY NAMEQuetiapine FumarateThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLETThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE3/27/2012This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERANDA090749This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEWest-Ward Pharmaceuticals CorpName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEQUETIAPINE FUMARATEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH50 
ACTIVE INGRED UNITmg/1 
PHARM CLASSESAtypical Antipsychotic [EPC] 

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This page was last updated on: 5/17/2019