cephalexin

Product NDC
12634-434
11-digit product format
126340434
Labeler code
12634
Product ID
12634-434_273003a5-23c4-21e4-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Apotheca Inc.
Application
ANDA065248
Marketing category
ANDA
Marketing start
2008-01-18
Marketing end
0000-00-00
Substance
CEPHALEXIN
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
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
12634-434-402020-01-31C16284748780-19d75b9cf-fb48-f424-e053-dadaa90a57ceCEPHALEXIN CAPSULES, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, cephalexin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
12634-434-712020-01-31C16284748780-19d75b9cf-fb48-f424-e053-dadaa90a57ceCEPHALEXIN CAPSULES, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, cephalexin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
12634-434-782020-01-31C16284748780-19d75b9cf-fb48-f424-e053-dadaa90a57ceCEPHALEXIN CAPSULES, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, cephalexin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
12634-434-802020-01-31C16284748780-19d75b9cf-fb48-f424-e053-dadaa90a57ceCEPHALEXIN CAPSULES, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, cephalexin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
12634-434-812020-01-31C16284748780-19d75b9cf-fb48-f424-e053-dadaa90a57ceCEPHALEXIN CAPSULES, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, cephalexin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
12634-434-842020-01-31C16284748780-19d75b9cf-fb48-f424-e053-dadaa90a57ceCEPHALEXIN CAPSULES, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, cephalexin 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
12634-434-40cephalexin40 in 1 BOTTLECAPSULE401
12634-434-71cephalexin30 in 1 BOTTLECAPSULE301
12634-434-78cephalexin28 in 1 BOTTLECAPSULE281
12634-434-80cephalexin20 in 1 BOTTLECAPSULE201
12634-434-81cephalexin21 in 1 BOTTLECAPSULE211
12634-434-84cephalexin14 in 1 BOTTLECAPSULE141

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
12634-434-40EA - Each12634-434b6c3ae48-3d0c-45f2-a114-2e494aee967712016-01-13
12634-434-71EA - Each12634-434ecd19a67-4737-4bdd-b219-4079824b582b12016-01-13
12634-434-80EA - Each12634-434ccba5caf-1a5a-4bd8-b7b9-87df86137b9e12016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-434CEPHALEXIN CAPSULE [APOTHECA INC.]1Legacy NDC, 6 package rows20151218_27307377-5668-2e3a-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSN27307377-5668-2e3a-e054-00144ff88e881
309114cephalexin 500 MG Oral CapsuleSCD27307377-5668-2e3a-e054-00144ff88e881
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY27307377-5668-2e3a-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-434-401263404344040 in 1 BOTTLEHistorical
12634-434-711263404347130 in 1 BOTTLEHistorical
12634-434-781263404347828 in 1 BOTTLEHistorical
12634-434-801263404348020 in 1 BOTTLEHistorical
12634-434-811263404348121 in 1 BOTTLEHistorical
12634-434-841263404348414 in 1 BOTTLEHistorical