FDA.reportPublic FDA data

Cephalexin

Product NDC
24979-154
11-digit product format
249790154
Labeler code
24979
Product ID
24979-154_ea48be90-eff5-464c-8c41-5dcda052b5d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
TWi Pharmaceuticals, Inc.
Application
ANDA065336
Marketing category
ANDA
Marketing start
2018-02-28
Marketing end
0000-00-00
Substance
CEPHALEXIN
Active strength
125 mg/5mL
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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
24979-154-142024-01-30C16284748780-11030e365-3a29-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN for oral suspension USP, for oral use Initial U.S. Approval: 1971
24979-154-382024-01-30C16284748780-11030e365-3a29-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN for oral suspension USP, for oral use Initial U.S. Approval: 1971

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24979-154-14Cephalexin100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1002
24979-154-38Cephalexin200 mL in 1 BOTTLEPOWDER, FOR SUSPENSION2002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24979-154-14ML - Milliliter24979-154a3d5e2e5-865e-44e4-aaf7-0ed0a057f85112018-03-08
24979-154-38ML - Milliliter24979-1544f4ed783-266b-4365-9954-87778b6caa5712018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24979-154CEPHALEXIN POWDER, FOR SUSPENSION [TWI PHARMACEUTICALS, INC.]2Legacy NDC, 2 package rows20190820_004fe393-962d-427c-93f4-31a48806ecf3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309110cephalexin 125 MG in 5 mL Oral SuspensionPSN004fe393-962d-427c-93f4-31a48806ecf32
309113cephalexin 250 MG in 5 mL Oral SuspensionPSN004fe393-962d-427c-93f4-31a48806ecf32
309110cephalexin 25 MG/ML Oral SuspensionSCD004fe393-962d-427c-93f4-31a48806ecf32
309113cephalexin 50 MG/ML Oral SuspensionSCD004fe393-962d-427c-93f4-31a48806ecf32
309110cefalexin 25 MG/ML Oral SuspensionSY004fe393-962d-427c-93f4-31a48806ecf32
309113cefalexin 50 MG/ML Oral SuspensionSY004fe393-962d-427c-93f4-31a48806ecf32
309110cephalexin 125 MG per 5 ML Oral SuspensionSY004fe393-962d-427c-93f4-31a48806ecf32
309113cephalexin 250 MG per 5 ML Oral SuspensionSY004fe393-962d-427c-93f4-31a48806ecf32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24979-154-1424979015414100 mL in 1 BOTTLE (24979-154-14) 100 ml2018-02-280000-00-00NoNoCurrent
24979-154-3824979015438200 mL in 1 BOTTLE (24979-154-38) 200 ml2018-02-280000-00-00NoNoCurrent