FDA.reportPublic FDA data

Cephalexin

Product NDC
52959-030
11-digit product format
529590030
Labeler code
52959
Product ID
52959-030_87894a01-9fab-4362-b6d4-f9a5f6a88d0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA065229
Marketing category
ANDA
Marketing start
2005-12-01
Marketing end
0000-00-00
Substance
CEPHALEXIN
Active strength
250 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
52959-030-012019-11-13C16284748780-197449f38-c335-f6ea-e053-dbdaa90aa703CEPHALEXIN CAPSULES USP
52959-030-082019-11-13C16284748780-197449f38-c335-f6ea-e053-dbdaa90aa703CEPHALEXIN CAPSULES USP
52959-030-122019-11-13C16284748780-197449f38-c335-f6ea-e053-dbdaa90aa703CEPHALEXIN CAPSULES USP
52959-030-202019-11-13C16284748780-197449f38-c335-f6ea-e053-dbdaa90aa703CEPHALEXIN CAPSULES USP
52959-030-242019-11-13C16284748780-197449f38-c335-f6ea-e053-dbdaa90aa703CEPHALEXIN CAPSULES USP
52959-030-282019-11-13C16284748780-197449f38-c335-f6ea-e053-dbdaa90aa703CEPHALEXIN CAPSULES USP
52959-030-302019-11-13C16284748780-197449f38-c335-f6ea-e053-dbdaa90aa703CEPHALEXIN CAPSULES USP
52959-030-402019-11-13C16284748780-197449f38-c335-f6ea-e053-dbdaa90aa703CEPHALEXIN CAPSULES USP
52959-030-562019-11-13C16284748780-197449f38-c335-f6ea-e053-dbdaa90aa703CEPHALEXIN CAPSULES USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-030-01Cephalexin100 in 1 BOTTLECAPSULE1003
52959-030-08Cephalexin8 in 1 BOTTLECAPSULE83
52959-030-12Cephalexin12 in 1 BOTTLECAPSULE123
52959-030-20Cephalexin20 in 1 BOTTLECAPSULE203
52959-030-24Cephalexin24 in 1 BOTTLECAPSULE243
52959-030-28Cephalexin28 in 1 BOTTLECAPSULE283
52959-030-30Cephalexin30 in 1 BOTTLECAPSULE303
52959-030-40Cephalexin40 in 1 BOTTLECAPSULE403
52959-030-56Cephalexin56 in 1 BOTTLECAPSULE563

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-030CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]3Legacy NDC, 9 package rows20120120_c5f1a7f6-a5a4-48f1-9022-d6d402bfd349.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309112cephalexin 250 MG Oral CapsulePSNc5f1a7f6-a5a4-48f1-9022-d6d402bfd3493
309112cephalexin 250 MG Oral CapsuleSCDc5f1a7f6-a5a4-48f1-9022-d6d402bfd3493
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSYc5f1a7f6-a5a4-48f1-9022-d6d402bfd3493

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-030-0152959003001100 in 1 BOTTLEHistorical
52959-030-08529590030088 in 1 BOTTLEHistorical
52959-030-125295900301212 in 1 BOTTLEHistorical
52959-030-205295900302020 in 1 BOTTLEHistorical
52959-030-245295900302424 in 1 BOTTLEHistorical
52959-030-285295900302828 in 1 BOTTLEHistorical
52959-030-305295900303030 in 1 BOTTLEHistorical
52959-030-405295900304040 in 1 BOTTLEHistorical
52959-030-565295900305656 in 1 BOTTLEHistorical