0527-2427 NDC - OLMESARTAN MEDOXOMIL ()

Drug Information

  • Product NDC: 0527-2427
  • Proprietary Name: OLMESARTAN MEDOXOMIL
  • Non Proprietary Name:
  • Active Ingredient(s): 40 mg/1 OLMESARTAN MEDOXOMIL
  • Administration Route(s):
  • Dosage Form(s):
  • Pharmacy Class(es): Angiotensin 2 Receptor Antagonists [MoA]; Angiotensin 2 Receptor Blocker [EPC]

Labeler Information

Field Name Field Value
Labeler Name: Lannett Company, Inc.
Product Type:
FDA Application Number: ANDA211049
Marketing Category: ANDA
Start Marketing Date:7/9/2021
End Marketing Date:7/23/2021

Package Information

No. Package Code Package Description Billing Unit
10527-2427-3230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-2427-32)EA
20527-2427-4690 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-2427-46)EA
30527-2427-5230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-2427-52)

NDC Record

Field Name Field Value Definition
PRODUCT NDC0527-2427The 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 NAMEOLMESARTAN MEDOXOMILThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE7/9/2021This 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 NUMBERANDA211049This 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 NAMELannett Company, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC0527-2427The 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 NAMEOLMESARTAN MEDOXOMILThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE3/5/2019This 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 NUMBERANDA211049This 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 NAMELannett Company, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 7/4/2025