Cephalexin

Product NDC
59651-783
11-digit product format
596510783
Labeler code
59651
Product ID
59651-783_e46059e1-3ce9-4a3c-80ce-464b140600ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA218817
Marketing category
ANDA
Marketing start
2024-09-27
Substance
CEPHALEXIN
Active strength
250 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cephalexin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEPHALEXIN250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOBN7UDS42Y
Rxcui197454, 309115

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
59651-783-01Cephalexin100 in 1 BOTTLETABLET, FILM COATED1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-783-01EA - Each59651-783492ff2bc-9b42-4aae-92bf-b7345b3f888912024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-783CEPHALEXIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1Current NDC, 1 package rows20241003_e46059e1-3ce9-4a3c-80ce-464b140600ce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309115cephalexin 250 MG Oral TabletPSNe46059e1-3ce9-4a3c-80ce-464b140600ce1
197454cephalexin 500 MG Oral TabletPSNe46059e1-3ce9-4a3c-80ce-464b140600ce1
309115cephalexin 250 MG Oral TabletSCDe46059e1-3ce9-4a3c-80ce-464b140600ce1
197454cephalexin 500 MG Oral TabletSCDe46059e1-3ce9-4a3c-80ce-464b140600ce1
309115cefalexin (as cefalexin monohydrate) 25 MG Oral TabletSYe46059e1-3ce9-4a3c-80ce-464b140600ce1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
59651-783-0159651078301100 TABLET, FILM COATED in 1 BOTTLE (59651-783-01) 2024-09-27NoNoCurrent