0093-8163 NDC - QUETIAPINE FUMARATE ()

Drug Information

  • Product NDC: 0093-8163
  • Proprietary Name: Quetiapine Fumarate
  • Non Proprietary Name:
  • Active Ingredient(s): 200 mg/1 QUETIAPINE FUMARATE
  • Administration Route(s):
  • Dosage Form(s):
  • Pharmacy Class(es): Atypical Antipsychotic [EPC]

Labeler Information

Field Name Field Value
Labeler Name: Teva Pharmaceuticals USA Inc
Product Type:
FDA Application Number: ANDA077745
Marketing Category: ANDA
Start Marketing Date:3/27/2012
End Marketing Date:7/18/2013

Package Information

No. Package Code Package Description Billing Unit
10093-8163-01100 TABLET, FILM COATED in 1 BOTTLE (0093-8163-01)EA
20093-8163-01100 TABLET, FILM COATED in 1 BOTTLE (0093-8163-01)EA
30093-8163-101000 TABLET, FILM COATED in 1 BOTTLE (0093-8163-10)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0093-8163The 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.
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 NUMBERANDA077745This 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 NAMETeva Pharmaceuticals USA IncName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC0093-8163The 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 NAMEQuetiapineThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
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 NUMBERANDA077745This 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 NAMETeva Pharmaceuticals USA, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 5/26/2025

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