FDA.reportPublic FDA data

Cephalexin

Product NDC
53002-2182
11-digit product format
530022182
Labeler code
53002
Product ID
53002-2182_89e7e532-d203-4675-a73d-38369e73e9d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA090836
Marketing category
ANDA
Marketing start
2011-01-19
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
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
53002-2182-12025-01-30C16284748780-19d75b9d0-bc50-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
53002-2182-22025-01-30C16284748780-19d75b9d0-bc50-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
53002-2182-32025-01-30C16284748780-19d75b9d0-bc50-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
53002-2182-42025-01-30C16284748780-19d75b9d0-bc50-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
53002-2182-52025-01-30C16284748780-19d75b9d0-bc50-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
53002-2182-62025-01-30C16284748780-19d75b9d0-bc50-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
53002-2182-92025-01-30C16284748780-19d75b9d0-bc50-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
53002-2182-12023-06-07C16284748780-19d75b9d0-bc50-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
53002-2182-22023-06-07C16284748780-19d75b9d0-bc50-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
53002-2182-32023-06-07C16284748780-19d75b9d0-bc50-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
53002-2182-42023-06-07C16284748780-19d75b9d0-bc50-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
53002-2182-52023-06-07C16284748780-19d75b9d0-bc50-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
53002-2182-62023-06-07C16284748780-19d75b9d0-bc50-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
53002-2182-92023-06-07C16284748780-19d75b9d0-bc50-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
53002-2182-12023-01-30C16284748780-19d75b9d0-bc50-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
53002-2182-22023-01-30C16284748780-19d75b9d0-bc50-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
53002-2182-32023-01-30C16284748780-19d75b9d0-bc50-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
53002-2182-42023-01-30C16284748780-19d75b9d0-bc50-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
53002-2182-52023-01-30C16284748780-19d75b9d0-bc50-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
53002-2182-62023-01-30C16284748780-19d75b9d0-bc50-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
53002-2182-92023-01-30C16284748780-19d75b9d0-bc50-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
53002-2182-12020-12-15C16284748780-19d75b9d0-bc50-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
53002-2182-22020-12-15C16284748780-19d75b9d0-bc50-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
53002-2182-32020-12-15C16284748780-19d75b9d0-bc50-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
53002-2182-42020-12-15C16284748780-19d75b9d0-bc50-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
53002-2182-52020-12-15C16284748780-19d75b9d0-bc50-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
53002-2182-62020-12-15C16284748780-19d75b9d0-bc50-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
53002-2182-92020-12-15C16284748780-19d75b9d0-bc50-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
53002-2182-12020-01-31C16284748780-19d75b9d0-bc50-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
53002-2182-22020-01-31C16284748780-19d75b9d0-bc50-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
53002-2182-32020-01-31C16284748780-19d75b9d0-bc50-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
53002-2182-42020-01-31C16284748780-19d75b9d0-bc50-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
53002-2182-52020-01-31C16284748780-19d75b9d0-bc50-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
53002-2182-62020-01-31C16284748780-19d75b9d0-bc50-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
53002-2182-92020-01-31C16284748780-19d75b9d0-bc50-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-2182-1Cephalexin100 in 1 BOTTLECAPSULE1005
53002-2182-2Cephalexin100 in 1 BOTTLECAPSULE1005
53002-2182-3Cephalexin100 in 1 BOTTLECAPSULE1005
53002-2182-4Cephalexin100 in 1 BOTTLECAPSULE1005
53002-2182-5Cephalexin100 in 1 BOTTLECAPSULE1005
53002-2182-6Cephalexin100 in 1 BOTTLECAPSULE1005
53002-2182-9Cephalexin100 in 1 BOTTLECAPSULE1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2182CEPHALEXIN CAPSULE [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 7 package rows20230609_ee96b574-39d4-4001-928f-733d4f6d4dc6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSNee96b574-39d4-4001-928f-733d4f6d4dc65
309114cephalexin 500 MG Oral CapsuleSCDee96b574-39d4-4001-928f-733d4f6d4dc65
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYee96b574-39d4-4001-928f-733d4f6d4dc65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-2182-153002218201100 CAPSULE in 1 BOTTLE (53002-2182-1) 100 capsule2018-10-010000-00-00NoNoCurrent
53002-2182-253002218202100 CAPSULE in 1 BOTTLE (53002-2182-2) 100 capsule2018-10-010000-00-00NoNoCurrent
53002-2182-353002218203100 CAPSULE in 1 BOTTLE (53002-2182-3) 100 capsule2018-10-010000-00-00NoNoCurrent
53002-2182-453002218204100 CAPSULE in 1 BOTTLE (53002-2182-4) 100 capsule2018-10-010000-00-00NoNoCurrent
53002-2182-553002218205100 CAPSULE in 1 BOTTLE (53002-2182-5) 100 capsule2018-10-010000-00-00NoNoCurrent
53002-2182-653002218206100 CAPSULE in 1 BOTTLE (53002-2182-6) 100 capsule2018-10-010000-00-00NoNoCurrent
53002-2182-953002218209100 CAPSULE in 1 BOTTLE (53002-2182-9) 100 capsule2018-10-010000-00-00NoNoCurrent