42543-407 NDC - POTASSIUM CITRATE

Drug Information

  • Product NDC: 42543-407
  • Proprietary Name: POTASSIUM CITRATE
  • Non Proprietary Name: POTASSIUM CITRATE
  • Active Ingredient(s): 10 meq/1 POTASSIUM CITRATE
  • Administration Route(s): ORAL
  • Dosage Form(s): TABLET
  • Pharmacy Class(es): Acidifying Activity [MoA]; Anti-coagulant [EPC]; Calcium Chelating Activity [MoA]; Calculi Dissolution Agent [EPC]; Decreased Coagulation Factor Activity [PE]

Labeler Information

Field Name Field Value
Labeler Name: Strides Pharma Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA206813
Marketing Category: ANDA
Start Marketing Date:11/1/2017

Package Information

No. Package Code Package Description Billing Unit
142543-407-01100 TABLET in 1 BOTTLE (42543-407-01)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC42543-407The 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 NAMEPOTASSIUM CITRATEThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
PROPRIETARY NAME SUFFIXEXTENDED RELEASEThe translation of the dosage form Code submitted by the firm.
NON PROPRIETARY NAMEPOTASSIUM CITRATEThis is the date that the labeler indicates was the start of its marketing of the drug product.
DOSAGE FORM NAMETABLETProduct 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.
ROUTE NAMEORALName of Company corresponding to the labeler code segment of the Product NDC.
START MARKETING DATE11/1/2017An 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.
MARKETING CATEGORY NAMEANDA 
APPLICATION NUMBERANDA206813 
LABELER NAMEStrides Pharma Inc.The 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.
SUBSTANCE NAMEPOTASSIUM CITRATEIndicates 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.
ACTIVE NUMERATOR STRENGTH10 
ACTIVE INGRED UNITmeq/1 
PHARM CLASSESAcidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE] 

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This page was last updated on: 12/19/2025

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