Cephalexin

Product NDC
10544-503
11-digit product format
105440503
Labeler code
10544
Product ID
10544-503_7d7a65bd-ef86-4b09-94c2-a26c1aa2b227
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA065248
Marketing category
ANDA
Marketing start
2009-12-22
Marketing end
0000-00-00
Substance
CEPHALEXIN
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dfa3f520-409c-432e-b6d3-9250d468c772Product name120250401
64bb7f1a-2c2e-4741-8301-dbfeda7239f6Product name120190628
398aa563-bb78-fe0f-46a8-757c40ef28bfProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10544-503-142019-10-21C16284748780-1956f9ecf-c096-621f-e053-dbdaa90a74adCEPHALEXIN CAPSULES, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
10544-503-202019-10-21C16284748780-1956f9ecf-c096-621f-e053-dbdaa90a74adCEPHALEXIN CAPSULES, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
10544-503-282019-10-21C16284748780-1956f9ecf-c096-621f-e053-dbdaa90a74adCEPHALEXIN CAPSULES, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
10544-503-302019-10-21C16284748780-1956f9ecf-c096-621f-e053-dbdaa90a74adCEPHALEXIN CAPSULES, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
10544-503-402019-10-21C16284748780-1956f9ecf-c096-621f-e053-dbdaa90a74adCEPHALEXIN CAPSULES, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-503-14Cephalexin14 in 1 BOTTLECAPSULE141
10544-503-20Cephalexin20 in 1 BOTTLECAPSULE201
10544-503-28Cephalexin28 in 1 BOTTLECAPSULE281
10544-503-30Cephalexin30 in 1 BOTTLECAPSULE301
10544-503-40Cephalexin40 in 1 BOTTLECAPSULE401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-503CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 5 package rows20100913_d5baab72-2d4b-42aa-973e-860a22b23a90.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSNd5baab72-2d4b-42aa-973e-860a22b23a901
309114cephalexin 500 MG Oral CapsuleSCDd5baab72-2d4b-42aa-973e-860a22b23a901
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYd5baab72-2d4b-42aa-973e-860a22b23a901

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-503-141054405031414 in 1 BOTTLEHistorical
10544-503-201054405032020 in 1 BOTTLEHistorical
10544-503-281054405032828 in 1 BOTTLEHistorical
10544-503-301054405033030 in 1 BOTTLEHistorical
10544-503-401054405034040 in 1 BOTTLEHistorical