FDA.reportPublic FDA data

Cephalexin

Product NDC
68788-7796
11-digit product format
687887796
Labeler code
68788
Product ID
68788-7796_42812958-ff3d-419e-8a10-25469a0efe53
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
Preferred Pharmaceuticlas Inc.
Application
ANDA210221
Marketing category
ANDA
Marketing start
2020-10-13
Substance
CEPHALEXIN
Active strength
125 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
CEPHALEXIN125 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOBN7UDS42Y
Rxcui309110

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7796-1Cephalexin100 mL in 1 BOTTLEFOR SUSPENSION1007
68788-7796-2Cephalexin200 mL in 1 BOTTLEFOR SUSPENSION2007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7796CEPHALEXIN FOR SUSPENSION [PREFERRED PHARMACEUTICLAS INC.]6Current NDC, Legacy NDC, 2 package rows20250223_fbf5fcdf-40fc-40e5-b784-308032fff0e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309110cephalexin 125 MG in 5 mL Oral SuspensionPSNfbf5fcdf-40fc-40e5-b784-308032fff0e57
309110cephalexin 25 MG/ML Oral SuspensionSCDfbf5fcdf-40fc-40e5-b784-308032fff0e57
309110cefalexin 25 MG/ML Oral SuspensionSYfbf5fcdf-40fc-40e5-b784-308032fff0e57
309110cephalexin 125 MG per 5 ML Oral SuspensionSYfbf5fcdf-40fc-40e5-b784-308032fff0e57

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7796-168788779601100 mL in 1 BOTTLE (68788-7796-1) 100 ml2020-10-130000-00-00NoNoCurrent
68788-7796-268788779602200 mL in 1 BOTTLE (68788-7796-2) 200 ml2020-10-130000-00-00NoNoCurrent