FDA.reportPublic FDA data

Cephalexin

Product NDC
68289-009
11-digit product format
682890009
Labeler code
68289
Product ID
68289-009_24fc53ef-d9ef-401a-8bbe-3fc0d76a6cf8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
SUSPENSION
Route
ORAL
Labeler
Jazeera Pharmaceutical
Application
ANDA065444
Marketing category
ANDA
Marketing start
2009-09-01
Marketing end
0000-00-00
Substance
CEPHALEXIN ANHYDROUS
Active strength
250 mg/5mL
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
68289-009-012019-10-21C16284748780-1956f9ecf-c2d6-621f-e053-dbdaa90a74adCephalexin for Oral Suspension USP
68289-009-202019-10-21C16284748780-1956f9ecf-c2d6-621f-e053-dbdaa90a74adCephalexin for Oral Suspension USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68289-009-01CephalexinUSP100 mL in 1 BOTTLESUSPENSION1002
68289-009-20CephalexinUSP200 mL in 1 BOTTLESUSPENSION2002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXIN ANHYDROUSACTIVE INGREDIENT5SFF1W6677CEPHALEXIN USP (CEPHALEXIN) SUSPENSION [JAZEERA PHARMACEUTICAL]2
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN USP (CEPHALEXIN) SUSPENSION [JAZEERA PHARMACEUTICAL]2
CITRIC ACIDINACTIVE INGREDIENT2968PHW8QPCEPHALEXIN USP (CEPHALEXIN) SUSPENSION [JAZEERA PHARMACEUTICAL]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACEPHALEXIN USP (CEPHALEXIN) SUSPENSION [JAZEERA PHARMACEUTICAL]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEPHALEXIN USP (CEPHALEXIN) SUSPENSION [JAZEERA PHARMACEUTICAL]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCEPHALEXIN USP (CEPHALEXIN) SUSPENSION [JAZEERA PHARMACEUTICAL]2
SUCROSEINACTIVE INGREDIENTC151H8M554CEPHALEXIN USP (CEPHALEXIN) SUSPENSION [JAZEERA PHARMACEUTICAL]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECEPHALEXIN USP (CEPHALEXIN) SUSPENSION [JAZEERA PHARMACEUTICAL]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68289-009CEPHALEXIN USP (CEPHALEXIN) SUSPENSION [JAZEERA PHARMACEUTICAL]2Legacy NDC, 2 package rows20090922_2b388b1e-cd59-42de-ba72-858485b070b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309110cephalexin 125 MG in 5 mL Oral SuspensionPSN2b388b1e-cd59-42de-ba72-858485b070b72
309113cephalexin 250 MG in 5 mL Oral SuspensionPSN2b388b1e-cd59-42de-ba72-858485b070b72
309110cephalexin 25 MG/ML Oral SuspensionSCD2b388b1e-cd59-42de-ba72-858485b070b72
309113cephalexin 50 MG/ML Oral SuspensionSCD2b388b1e-cd59-42de-ba72-858485b070b72
309110cefalexin 25 MG/ML Oral SuspensionSY2b388b1e-cd59-42de-ba72-858485b070b72
309113cefalexin 50 MG/ML Oral SuspensionSY2b388b1e-cd59-42de-ba72-858485b070b72
309110cephalexin 125 MG per 5 ML Oral SuspensionSY2b388b1e-cd59-42de-ba72-858485b070b72
309113cephalexin 250 MG per 5 ML Oral SuspensionSY2b388b1e-cd59-42de-ba72-858485b070b72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
68289-009-0168289000901100 mL in 1 BOTTLE100 mlHistorical
68289-009-2068289000920200 mL in 1 BOTTLE200 mlHistorical