FDA.reportPublic FDA data

Cephalexin

Product NDC
68071-2726
11-digit product format
680712726
Labeler code
68071
Product ID
68071-2726_dfafc221-3446-71a1-e053-2a95a90a6301
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA062702
Marketing category
ANDA
Marketing start
1990-09-30
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
2023-12-31
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
68071-2726-42025-01-30C16284748780-12cef2736-a7bf-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971
68071-2726-62025-01-30C16284748780-12cef2736-a7bf-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2726-4Cephalexin4 in 1 BOTTLECAPSULE42
68071-2726-6Cephalexin6 in 1 BOTTLECAPSULE62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2726CEPHALEXIN CAPSULE [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 2 package rows20230803_dfafbc14-da81-4878-e053-2995a90a0358.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSNdfafbc14-da81-4878-e053-2995a90a03582
309114cephalexin 500 MG Oral CapsuleSCDdfafbc14-da81-4878-e053-2995a90a03582
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYdfafbc14-da81-4878-e053-2995a90a03582

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2726-4680712726044 in 1 BOTTLEHistorical
68071-2726-6680712726066 CAPSULE in 1 BOTTLE (68071-2726-6) 6 capsule2022-05-230000-00-00NoNoCurrent