69543-381 NDC - OLANZAPINE ()

Drug Information

  • Product NDC: 69543-381
  • Proprietary Name: Olanzapine
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: Virtus Pharmaceuticals, LLC
Product Type:
FDA Application Number: ANDA204319
Marketing Category: ANDA
Start Marketing Date:1/19/2018
End Marketing Date:8/31/2024

Package Information

No. Package Code Package Description Billing Unit
169543-381-3030 TABLET in 1 BOTTLE (69543-381-30)EA
269543-381-9090 TABLET in 1 BOTTLE (69543-381-90)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC69543-381This 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.
PROPRIETARY NAMEOlanzapineName of Company corresponding to the labeler code segment of the Product NDC.
START MARKETING DATE1/19/2018The 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.
END MARKETING DATE8/31/2024The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
MARKETING CATEGORY NAMEANDAA 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.
APPLICATION NUMBERANDA204319This 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 NAMEVirtus Pharmaceuticals, LLCName of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 1/2/2026

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