FDA.reportPublic FDA data

Cephalexin

Product NDC
61442-201
11-digit product format
614420201
Labeler code
61442
Product ID
61442-201_e3757196-10ac-43b5-8ce1-2da9cbda14c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
SUSPENSION
Route
ORAL
Labeler
Carlsbad Technology, Inc.
Application
ANDA065336
Marketing category
ANDA
Marketing start
2009-06-01
Marketing end
0000-00-00
Substance
CEPHALEXIN
Active strength
125 mg/5mL
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
61442-201-012019-10-29C16284748780-1960f7f55-c6b6-8e05-e053-dbdaa90a074aCEPHALEXIN FOR ORAL SUSPENSION USP
61442-201-022019-10-29C16284748780-1960f7f55-c6b6-8e05-e053-dbdaa90a074aCEPHALEXIN FOR ORAL SUSPENSION USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61442-201-01Cephalexin24 in 1 BOXSUSPENSION243
61442-201-01Cephalexin100 mL in 1 BOTTLESUSPENSION1003
61442-201-02Cephalexin24 in 1 BOXSUSPENSION243
61442-201-02Cephalexin200 mL in 1 BOTTLESUSPENSION2003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61442-201-01ML - Milliliter61442-2018bab2e97-77ba-43b8-860d-3e23a8d439d212012-07-24
61442-201-02ML - Milliliter61442-20170a10c0d-f139-4c22-9e36-c128f930b9b312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CephalexinACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN SUSPENSION [CARLSBAD TECHNOLOGY, INC.]3
CephalexinACTIVE MOIETYOBN7UDS42YCEPHALEXIN SUSPENSION [CARLSBAD TECHNOLOGY, INC.]3
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOACEPHALEXIN SUSPENSION [CARLSBAD TECHNOLOGY, INC.]3
Methylcellulose (25 CPS)INACTIVE INGREDIENTBI55GG2WLICEPHALEXIN SUSPENSION [CARLSBAD TECHNOLOGY, INC.]3
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JCEPHALEXIN SUSPENSION [CARLSBAD TECHNOLOGY, INC.]3
StrawberryINACTIVE INGREDIENT4J2TY8Y81VCEPHALEXIN SUSPENSION [CARLSBAD TECHNOLOGY, INC.]3
SucroseINACTIVE INGREDIENTC151H8M554CEPHALEXIN SUSPENSION [CARLSBAD TECHNOLOGY, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61442-201CEPHALEXIN SUSPENSION [CARLSBAD TECHNOLOGY, INC.]3Legacy NDC, 4 package rows20101007_22ab5dba-bfce-498d-a644-9ca0e343b1cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309110cephalexin 125 MG in 5 mL Oral SuspensionPSN22ab5dba-bfce-498d-a644-9ca0e343b1cf3
309113cephalexin 250 MG in 5 mL Oral SuspensionPSN22ab5dba-bfce-498d-a644-9ca0e343b1cf3
309110cephalexin 25 MG/ML Oral SuspensionSCD22ab5dba-bfce-498d-a644-9ca0e343b1cf3
309113cephalexin 50 MG/ML Oral SuspensionSCD22ab5dba-bfce-498d-a644-9ca0e343b1cf3
309110cefalexin 25 MG/ML Oral SuspensionSY22ab5dba-bfce-498d-a644-9ca0e343b1cf3
309113cefalexin 50 MG/ML Oral SuspensionSY22ab5dba-bfce-498d-a644-9ca0e343b1cf3
309110cephalexin 125 MG per 5 ML Oral SuspensionSY22ab5dba-bfce-498d-a644-9ca0e343b1cf3
309113cephalexin 250 MG per 5 ML Oral SuspensionSY22ab5dba-bfce-498d-a644-9ca0e343b1cf3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61442-201-016144202010124 in 1 BOXHistorical
61442-201-026144202010224 in 1 BOXHistorical