43063-497 NDC - CEPHALEXIN

Drug Information

  • Product NDC: 43063-497
  • Proprietary Name: Cephalexin
  • Non Proprietary Name: Cephalexin
  • Active Ingredient(s): 250 mg/1 CEPHALEXIN
  • Administration Route(s): ORAL
  • Dosage Form(s): CAPSULE
  • Pharmacy Class(es): Cephalosporin Antibacterial [EPC]; Cephalosporins [CS]

Labeler Information

Field Name Field Value
Labeler Name: PD-Rx Pharmaceuticals, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA090836
Marketing Category: ANDA
Start Marketing Date:1/20/2011

Package Information

No. Package Code Package Description Billing Unit
143063-497-044 CAPSULE in 1 BOTTLE, PLASTIC (43063-497-04)EA
243063-497-066 CAPSULE in 1 BOTTLE, PLASTIC (43063-497-06)EA
343063-497-088 CAPSULE in 1 BOTTLE, PLASTIC (43063-497-08)EA
443063-497-099 CAPSULE in 1 BOTTLE, PLASTIC (43063-497-09)EA
543063-497-1010 CAPSULE in 1 BOTTLE, PLASTIC (43063-497-10)EA
643063-497-1515 CAPSULE in 1 BOTTLE, PLASTIC (43063-497-15)EA
743063-497-2020 CAPSULE in 1 BOTTLE, PLASTIC (43063-497-20)EA
843063-497-2828 CAPSULE in 1 BOTTLE, PLASTIC (43063-497-28)EA
943063-497-3030 CAPSULE in 1 BOTTLE, PLASTIC (43063-497-30)EA
1043063-497-4040 CAPSULE in 1 BOTTLE, PLASTIC (43063-497-40)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC43063-497The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
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 NAMECephalexinProduct 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 NAMECephalexinName of Company corresponding to the labeler code segment of the Product NDC.
DOSAGE FORM NAMECAPSULEThis is the date that the labeler indicates was the start of its marketing of the drug product.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE1/20/2011Name of Company corresponding to the labeler code segment of the Product NDC.
MARKETING CATEGORY NAMEANDAAn 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.
APPLICATION NUMBERANDA090836 
LABELER NAMEPD-Rx Pharmaceuticals, Inc. 
SUBSTANCE NAMECEPHALEXIN 
ACTIVE NUMERATOR STRENGTH250 
ACTIVE INGRED UNITmg/1 
PHARM CLASSESCephalosporin Antibacterial [EPC], Cephalosporins [CS] 

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This page was last updated on: 11/21/2025

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