FDA.reportPublic FDA data

Cephalexin

Product NDC
68788-7529
11-digit product format
687887529
Labeler code
68788
Product ID
68788-7529_9594872a-00ca-4029-b567-af0cc2b9bda2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA210221
Marketing category
ANDA
Marketing start
2019-03-28
Substance
CEPHALEXIN
Active strength
250 mg/5mL
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cephalexin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEPHALEXIN250 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOBN7UDS42Y
Rxcui309113

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
68788-7529-12021-02-03C16284748780-1ba0f9c33-4a82-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use CEPHALEXIN FOR ORAL SUSPENSION safely and effectively. See full prescribing information for CEPHALEXIN FOR ORAL SUSPENSION CEPHALEXIN for oral suspension Initial U.S. Approval: 1971
68788-7529-22021-02-03C16284748780-1ba0f9c33-4a82-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use CEPHALEXIN FOR ORAL SUSPENSION safely and effectively. See full prescribing information for CEPHALEXIN FOR ORAL SUSPENSION CEPHALEXIN for oral suspension Initial U.S. Approval: 1971
68788-7529-12021-01-29C16284748780-1ba0f9c33-4a82-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use CEPHALEXIN FOR ORAL SUSPENSION safely and effectively. See full prescribing information for CEPHALEXIN FOR ORAL SUSPENSION CEPHALEXIN for oral suspension Initial U.S. Approval: 1971
68788-7529-22021-01-29C16284748780-1ba0f9c33-4a82-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use CEPHALEXIN FOR ORAL SUSPENSION safely and effectively. See full prescribing information for CEPHALEXIN FOR ORAL SUSPENSION CEPHALEXIN for oral suspension Initial U.S. Approval: 1971

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7529-1Cephalexin100 mL in 1 BOTTLEFOR SUSPENSION1007
68788-7529-2Cephalexin200 mL in 1 BOTTLEFOR SUSPENSION2007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7529CEPHALEXIN FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 2 package rows20250223_6c7bfa58-2d38-4607-8c33-485ba4931c68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309113cephalexin 250 MG in 5 mL Oral SuspensionPSN6c7bfa58-2d38-4607-8c33-485ba4931c687
309113cephalexin 50 MG/ML Oral SuspensionSCD6c7bfa58-2d38-4607-8c33-485ba4931c687
309113cefalexin 50 MG/ML Oral SuspensionSY6c7bfa58-2d38-4607-8c33-485ba4931c687
309113cephalexin 250 MG per 5 ML Oral SuspensionSY6c7bfa58-2d38-4607-8c33-485ba4931c687

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7529-168788752901100 mL in 1 BOTTLE (68788-7529-1) 100 ml2019-10-040000-00-00NoNoCurrent
68788-7529-268788752902200 mL in 1 BOTTLE (68788-7529-2) 200 ml2019-10-040000-00-00NoNoCurrent