55154-2327 NDC - LOSARTAN POTASSIUM

Drug Information

  • Product NDC: 55154-2327
  • Proprietary Name: Losartan Potassium
  • Non Proprietary Name: Losartan Potassium
  • Active Ingredient(s): 50 mg/1 LOSARTAN POTASSIUM
  • Administration Route(s): ORAL
  • Dosage Form(s): TABLET, FILM COATED
  • Pharmacy Class(es): Angiotensin 2 Receptor Antagonists [MoA]; Angiotensin 2 Receptor Blocker [EPC]

Labeler Information

Field Name Field Value
Labeler Name: Cardinal Health 107, LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA078243
Marketing Category: ANDA
Start Marketing Date:10/4/2010

Package Information

No. Package Code Package Description Billing Unit
155154-2327-010 BLISTER PACK in 1 BAG (55154-2327-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK

NDC Record

Field Name Field Value Definition
PRODUCT NDC55154-2327The translation of the route code submitted by the firm, indicating route of administration.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGThis is the date that the labeler indicates was the start of its marketing of the drug product.
PROPRIETARY NAMELosartan PotassiumProduct 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.
NON PROPRIETARY NAMELosartan PotassiumThis 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.
DOSAGE FORM NAMETABLET, FILM COATEDThe 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 DATE10/4/2010This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDA 
APPLICATION NUMBERANDA078243 
LABELER NAMECardinal Health 107, LLC 
SUBSTANCE NAMELOSARTAN POTASSIUMAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH50 
ACTIVE INGRED UNITmg/1 
PHARM CLASSESAngiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC] 

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This page was last updated on: 12/6/2025

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