FDA.reportPublic FDA data

Cephalexin

Product NDC
50090-3291
11-digit product format
500903291
Labeler code
50090
Product ID
50090-3291_dbc11722-8b07-4d5c-8639-38e76d9536a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090836
Marketing category
ANDA
Marketing start
2011-01-20
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3291-02023-02-07C16284748780-1f386c64a-37f3-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
50090-3291-02023-01-30C16284748780-1f386c64a-37f3-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3291-0Cephalexin40 in 1 BOTTLECAPSULE4019
50090-3291-1Cephalexin28 in 1 BOTTLECAPSULE2819

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3291CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS]19Current NDC, Legacy NDC, 2 package rows20240529_73920373-b45d-45d6-b183-d962467dde36.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309112cephalexin 250 MG Oral CapsulePSN73920373-b45d-45d6-b183-d962467dde3619
309114cephalexin 500 MG Oral CapsulePSN73920373-b45d-45d6-b183-d962467dde3619
309112cephalexin 250 MG Oral CapsuleSCD73920373-b45d-45d6-b183-d962467dde3619
309114cephalexin 500 MG Oral CapsuleSCD73920373-b45d-45d6-b183-d962467dde3619
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY73920373-b45d-45d6-b183-d962467dde3619
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY73920373-b45d-45d6-b183-d962467dde3619

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3291-05009032910040 CAPSULE in 1 BOTTLE (50090-3291-0) 40 capsule2017-12-010000-00-00NoNoCurrent
50090-3291-15009032910128 CAPSULE in 1 BOTTLE (50090-3291-1) 28 capsule2023-12-15NoNoCurrent