FDA.reportPublic FDA data

Cephalexin

Product NDC
50090-4423
11-digit product format
500904423
Labeler code
50090
Product ID
50090-4423_a8e85d83-6049-42c9-87da-b7fb185ce0e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA062702
Marketing category
ANDA
Marketing start
1990-09-30
Marketing end
0000-00-00
Substance
CEPHALEXIN
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
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
50090-4423-02023-01-30C16284748780-1f386c64a-182d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, CEPHALEXIN for oral suspension, and CEPHALEXIN tablets, for oral use Initial U.S. Approval: 1971
50090-4423-12023-01-30C16284748780-1f386c64a-182d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, CEPHALEXIN for oral suspension, and CEPHALEXIN tablets, for oral use Initial U.S. Approval: 1971

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4423-0Cephalexin30 in 1 BOTTLECAPSULE301
50090-4423-1Cephalexin30 in 1 BOTTLECAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4423CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20200710_0a0fb85d-a7bc-4a5b-b389-bd91c8ffc697.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSN0a0fb85d-a7bc-4a5b-b389-bd91c8ffc6971
309114cephalexin 500 MG Oral CapsuleSCD0a0fb85d-a7bc-4a5b-b389-bd91c8ffc6971
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY0a0fb85d-a7bc-4a5b-b389-bd91c8ffc6971

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4423-05009044230030 CAPSULE in 1 BOTTLE (50090-4423-0) 30 capsule2019-07-190000-00-00NoNoCurrent
50090-4423-15009044230130 CAPSULE in 1 BOTTLE (50090-4423-1) 30 capsule2019-07-190000-00-00NoNoCurrent