FDA.reportPublic FDA data

Cephalexin

Product NDC
50090-0079
11-digit product format
500900079
Labeler code
50090
Product ID
50090-0079_4a51af0b-3c86-49da-99b3-5fc4309b2690
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065253
Marketing category
ANDA
Marketing start
2005-11-16
Substance
CEPHALEXIN
Active strength
500 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
CEPHALEXIN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOBN7UDS42Y
Rxcui309112, 309114

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
50090-0079-0Cephalexin20 in 1 BOTTLECAPSULE2014
50090-0079-1Cephalexin28 in 1 BOTTLECAPSULE2814
50090-0079-2Cephalexin40 in 1 BOTTLECAPSULE4014
50090-0079-3Cephalexin14 in 1 BOTTLECAPSULE1414
50090-0079-5Cephalexin10 in 1 BOTTLECAPSULE1014
50090-0079-6Cephalexin30 in 1 BOTTLECAPSULE3014
50090-0079-7Cephalexin100 in 1 BOTTLECAPSULE10014
50090-0079-8Cephalexin4 in 1 BOTTLECAPSULE414

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0079CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS]14Current NDC, Legacy NDC, 8 package rows20241027_99ef59d5-bc44-4727-86fe-dc81357207c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309112cephalexin 250 MG Oral CapsulePSN99ef59d5-bc44-4727-86fe-dc81357207c314
309114cephalexin 500 MG Oral CapsulePSN99ef59d5-bc44-4727-86fe-dc81357207c314
309112cephalexin 250 MG Oral CapsuleSCD99ef59d5-bc44-4727-86fe-dc81357207c314
309114cephalexin 500 MG Oral CapsuleSCD99ef59d5-bc44-4727-86fe-dc81357207c314
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY99ef59d5-bc44-4727-86fe-dc81357207c314
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY99ef59d5-bc44-4727-86fe-dc81357207c314

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-0079-05009000790020 CAPSULE in 1 BOTTLE (50090-0079-0) 20 capsule2014-11-28NoNoCurrent
50090-0079-15009000790128 CAPSULE in 1 BOTTLE (50090-0079-1) 28 capsule2014-11-28NoNoCurrent
50090-0079-25009000790240 CAPSULE in 1 BOTTLE (50090-0079-2) 40 capsule2014-11-28NoNoCurrent
50090-0079-35009000790314 CAPSULE in 1 BOTTLE (50090-0079-3) 14 capsule2014-11-28NoNoCurrent
50090-0079-55009000790510 CAPSULE in 1 BOTTLE (50090-0079-5) 10 capsule2014-11-28NoNoCurrent
50090-0079-65009000790630 CAPSULE in 1 BOTTLE (50090-0079-6) 30 capsule2014-11-28NoNoCurrent
50090-0079-750090007907100 CAPSULE in 1 BOTTLE (50090-0079-7) 100 capsule2014-11-28NoNoCurrent
50090-0079-8500900079084 CAPSULE in 1 BOTTLE (50090-0079-8) 4 capsule2014-11-28NoNoCurrent