FDA.reportPublic FDA data

Cephalexin

Product NDC
59834-203
11-digit product format
598340203
Labeler code
59834
Product ID
59834-203_d44b632d-0f53-4063-9479-27b5f9a92727
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
OrchidPharma Inc
Application
ANDA065326
Marketing category
ANDA
Marketing start
2011-09-01
Marketing end
0000-00-00
Substance
CEPHALEXIN
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
59834-203-172019-11-13C16284748780-197449f38-bae3-f6ea-e053-dbdaa90aa703CEPHALEXIN FOR ORAL SUSPENSION, USP Rx only
59834-203-472019-11-13C16284748780-197449f38-bae3-f6ea-e053-dbdaa90aa703CEPHALEXIN FOR ORAL SUSPENSION, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59834-203-17Cephalexin100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1002
59834-203-47Cephalexin200 mL in 1 BOTTLEPOWDER, FOR SUSPENSION2002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN POWDER, FOR SUSPENSION [ORCHIDPHARMA INC]2
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN POWDER, FOR SUSPENSION [ORCHIDPHARMA INC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEPHALEXIN POWDER, FOR SUSPENSION [ORCHIDPHARMA INC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEPHALEXIN POWDER, FOR SUSPENSION [ORCHIDPHARMA INC]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEPHALEXIN POWDER, FOR SUSPENSION [ORCHIDPHARMA INC]2
SUCROSEINACTIVE INGREDIENTC151H8M554CEPHALEXIN POWDER, FOR SUSPENSION [ORCHIDPHARMA INC]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECEPHALEXIN POWDER, FOR SUSPENSION [ORCHIDPHARMA INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59834-203CEPHALEXIN POWDER, FOR SUSPENSION [ORCHIDPHARMA INC]2Legacy NDC, 2 package rows20120831_cb31cd1b-100d-4a24-b314-1ddcd6a95314.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309110cephalexin 125 MG in 5 mL Oral SuspensionPSNcb31cd1b-100d-4a24-b314-1ddcd6a953142
309113cephalexin 250 MG in 5 mL Oral SuspensionPSNcb31cd1b-100d-4a24-b314-1ddcd6a953142
309110cephalexin 25 MG/ML Oral SuspensionSCDcb31cd1b-100d-4a24-b314-1ddcd6a953142
309113cephalexin 50 MG/ML Oral SuspensionSCDcb31cd1b-100d-4a24-b314-1ddcd6a953142
309110cefalexin 25 MG/ML Oral SuspensionSYcb31cd1b-100d-4a24-b314-1ddcd6a953142
309113cefalexin 50 MG/ML Oral SuspensionSYcb31cd1b-100d-4a24-b314-1ddcd6a953142
309110cephalexin 125 MG per 5 ML Oral SuspensionSYcb31cd1b-100d-4a24-b314-1ddcd6a953142
309113cephalexin 250 MG per 5 ML Oral SuspensionSYcb31cd1b-100d-4a24-b314-1ddcd6a953142

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
59834-203-1759834020317100 mL in 1 BOTTLE100 mlHistorical
59834-203-4759834020347200 mL in 1 BOTTLE200 mlHistorical