FDA.reportPublic FDA data

Cephalexin

Product NDC
52959-031
11-digit product format
529590031
Labeler code
52959
Product ID
52959-031_749fe83a-d77e-46c1-8f31-6f318af9a2da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA065215
Marketing category
ANDA
Marketing start
2006-02-01
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
52959-031-002019-11-13C16284748780-197449f38-d5c8-f6ea-e053-dbdaa90aa703CEPHALEXIN CAPSULES, USP
52959-031-022019-11-13C16284748780-197449f38-d5c8-f6ea-e053-dbdaa90aa703CEPHALEXIN CAPSULES, USP
52959-031-042019-11-13C16284748780-197449f38-d5c8-f6ea-e053-dbdaa90aa703CEPHALEXIN CAPSULES, USP
52959-031-062019-11-13C16284748780-197449f38-d5c8-f6ea-e053-dbdaa90aa703CEPHALEXIN CAPSULES, USP
52959-031-082019-11-13C16284748780-197449f38-d5c8-f6ea-e053-dbdaa90aa703CEPHALEXIN CAPSULES, USP
52959-031-102019-11-13C16284748780-197449f38-d5c8-f6ea-e053-dbdaa90aa703CEPHALEXIN CAPSULES, USP
52959-031-122019-11-13C16284748780-197449f38-d5c8-f6ea-e053-dbdaa90aa703CEPHALEXIN CAPSULES, USP
52959-031-142019-11-13C16284748780-197449f38-d5c8-f6ea-e053-dbdaa90aa703CEPHALEXIN CAPSULES, USP
52959-031-152019-11-13C16284748780-197449f38-d5c8-f6ea-e053-dbdaa90aa703CEPHALEXIN CAPSULES, USP
52959-031-202019-11-13C16284748780-197449f38-d5c8-f6ea-e053-dbdaa90aa703CEPHALEXIN CAPSULES, USP
52959-031-212019-11-13C16284748780-197449f38-d5c8-f6ea-e053-dbdaa90aa703CEPHALEXIN CAPSULES, USP
52959-031-242019-11-13C16284748780-197449f38-d5c8-f6ea-e053-dbdaa90aa703CEPHALEXIN CAPSULES, USP
52959-031-282019-11-13C16284748780-197449f38-d5c8-f6ea-e053-dbdaa90aa703CEPHALEXIN CAPSULES, USP
52959-031-302019-11-13C16284748780-197449f38-d5c8-f6ea-e053-dbdaa90aa703CEPHALEXIN CAPSULES, USP
52959-031-402019-11-13C16284748780-197449f38-d5c8-f6ea-e053-dbdaa90aa703CEPHALEXIN CAPSULES, USP
52959-031-562019-11-13C16284748780-197449f38-d5c8-f6ea-e053-dbdaa90aa703CEPHALEXIN CAPSULES, USP
52959-031-602019-11-13C16284748780-197449f38-d5c8-f6ea-e053-dbdaa90aa703CEPHALEXIN CAPSULES, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-031-00Cephalexin100 in 1 BOTTLE, PLASTICCAPSULE1003
52959-031-02Cephalexin120 in 1 BOTTLE, PLASTICCAPSULE1203
52959-031-04Cephalexin4 in 1 BOTTLE, PLASTICCAPSULE43
52959-031-06Cephalexin6 in 1 BOTTLE, PLASTICCAPSULE63
52959-031-08Cephalexin8 in 1 BOTTLE, PLASTICCAPSULE83
52959-031-10Cephalexin500 in 1 BOTTLE, PLASTICCAPSULE5003
52959-031-12Cephalexin12 in 1 BOTTLE, PLASTICCAPSULE123
52959-031-14Cephalexin14 in 1 BOTTLE, PLASTICCAPSULE143
52959-031-15Cephalexin15 in 1 BOTTLE, PLASTICCAPSULE153
52959-031-20Cephalexin20 in 1 BOTTLE, PLASTICCAPSULE203
52959-031-21Cephalexin21 in 1 BOTTLE, PLASTICCAPSULE213
52959-031-24Cephalexin24 in 1 BOTTLE, PLASTICCAPSULE243
52959-031-28Cephalexin28 in 1 BOTTLE, PLASTICCAPSULE283
52959-031-30Cephalexin30 in 1 BOTTLE, PLASTICCAPSULE303
52959-031-40Cephalexin40 in 1 BOTTLE, PLASTICCAPSULE403
52959-031-56Cephalexin56 in 1 BOTTLE, PLASTICCAPSULE563
52959-031-60Cephalexin60 in 1 BOTTLE, PLASTICCAPSULE603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-031-00EA - Each52959-031f001b786-67f6-42c2-8e84-32ab73f9b0cb12012-07-24
52959-031-02EA - Each52959-03176af6e5a-7e99-4885-b1ce-8995d15936ca12012-07-24
52959-031-04EA - Each52959-0312101ea29-b107-4a7d-935f-0eceef6bcb3d12012-07-24
52959-031-06EA - Each52959-0318b017789-5743-442d-94da-2ea32a4b17ae12012-07-24
52959-031-08EA - Each52959-031e0c43631-5315-4650-b7d7-4f8b98653a9a12012-07-24
52959-031-10EA - Each52959-0314d20e684-257c-4c65-a10e-6a12b921687212012-07-24
52959-031-12EA - Each52959-031f4d63273-6046-4e26-bbfa-18a9768b18af12012-07-24
52959-031-14EA - Each52959-0312ebf4e18-c044-4eb5-ae84-e10a0380177d12012-07-24
52959-031-15EA - Each52959-031bb8d462f-a732-434d-ad06-54b5f5c69c9e12012-07-24
52959-031-20EA - Each52959-03146138811-27f1-4b19-8e35-3cca22c3934d12012-07-24
52959-031-21EA - Each52959-0319a5236e1-1123-465e-a489-8897c8850f0612012-07-24
52959-031-24EA - Each52959-0311a5d77ec-b29b-40ea-9ae0-706704faa8f612012-07-24
52959-031-28EA - Each52959-031f0baab14-4c4a-4e5c-af3e-6a1f450471da12012-07-24
52959-031-30EA - Each52959-031f09c9cce-c46c-4f7e-9840-53ec7ce06e4112012-07-24
52959-031-40EA - Each52959-03179dfedbf-9866-41cb-840f-e57c8ccdf22c12012-07-24
52959-031-56EA - Each52959-031dc41502a-6416-474f-b2b3-5810c011126a12012-07-24
52959-031-60EA - Each52959-0313ad14c7d-ef7c-4a47-859a-5d21279b414a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]3
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-031CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]3Legacy NDC, 17 package rows20111227_effe46a4-c383-4171-8ab4-2af9de316f08.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSNeffe46a4-c383-4171-8ab4-2af9de316f083
309114cephalexin 500 MG Oral CapsuleSCDeffe46a4-c383-4171-8ab4-2af9de316f083
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYeffe46a4-c383-4171-8ab4-2af9de316f083

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-031-0052959003100100 in 1 BOTTLE, PLASTICHistorical
52959-031-0252959003102120 in 1 BOTTLE, PLASTICHistorical
52959-031-04529590031044 in 1 BOTTLE, PLASTICHistorical
52959-031-06529590031066 in 1 BOTTLE, PLASTICHistorical
52959-031-08529590031088 in 1 BOTTLE, PLASTICHistorical
52959-031-1052959003110500 in 1 BOTTLE, PLASTICHistorical
52959-031-125295900311212 in 1 BOTTLE, PLASTICHistorical
52959-031-145295900311414 in 1 BOTTLE, PLASTICHistorical
52959-031-155295900311515 in 1 BOTTLE, PLASTICHistorical
52959-031-205295900312020 in 1 BOTTLE, PLASTICHistorical
52959-031-215295900312121 in 1 BOTTLE, PLASTICHistorical
52959-031-245295900312424 in 1 BOTTLE, PLASTICHistorical
52959-031-285295900312828 in 1 BOTTLE, PLASTICHistorical
52959-031-305295900313030 in 1 BOTTLE, PLASTICHistorical
52959-031-405295900314040 in 1 BOTTLE, PLASTICHistorical
52959-031-565295900315656 in 1 BOTTLE, PLASTICHistorical
52959-031-605295900316060 in 1 BOTTLE, PLASTICHistorical