FDA.reportPublic FDA data

Cephalexin

Product NDC
53002-2260
11-digit product format
530022260
Labeler code
53002
Product ID
53002-2260_0cefea87-3a1e-42ec-a818-deff31b8b0e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA065229
Marketing category
ANDA
Marketing start
2006-01-11
Marketing end
0000-00-00
Substance
CEPHALEXIN
Active strength
250 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
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
53002-2260-42025-01-30C16284748780-19d75b9d0-90e5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES USP safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES USP CEPHALEXIN capsules USP, for oral use Initial U.S. Approval: 1971
53002-2260-42023-06-07C16284748780-19d75b9d0-90e5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES USP safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES USP CEPHALEXIN capsules USP, for oral use Initial U.S. Approval: 1971
53002-2260-42023-01-30C16284748780-19d75b9d0-90e5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES USP safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES USP CEPHALEXIN capsules USP, for oral use Initial U.S. Approval: 1971
53002-2260-42020-12-15C16284748780-19d75b9d0-90e5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES USP safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES USP CEPHALEXIN capsules USP, for oral use Initial U.S. Approval: 1971
53002-2260-42020-01-31C16284748780-19d75b9d0-90e5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES USP safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES USP CEPHALEXIN capsules USP, for oral use Initial U.S. Approval: 1971

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-2260-4Cephalexin100 in 1 BOTTLECAPSULE1009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2260CEPHALEXIN CAPSULE [RPK PHARMACEUTICALS, INC.]9Legacy NDC, 1 package rows20230609_ec8f8062-a065-41d8-a2ad-97aa49bf1c27.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309112cephalexin 250 MG Oral CapsulePSNec8f8062-a065-41d8-a2ad-97aa49bf1c279
309114cephalexin 500 MG Oral CapsulePSNec8f8062-a065-41d8-a2ad-97aa49bf1c279
309112cephalexin 250 MG Oral CapsuleSCDec8f8062-a065-41d8-a2ad-97aa49bf1c279
309114cephalexin 500 MG Oral CapsuleSCDec8f8062-a065-41d8-a2ad-97aa49bf1c279
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYec8f8062-a065-41d8-a2ad-97aa49bf1c279
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSYec8f8062-a065-41d8-a2ad-97aa49bf1c279

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-2260-453002226004100 CAPSULE in 1 BOTTLE (53002-2260-4) 100 capsule2018-10-010000-00-00NoNoCurrent