FDA.reportPublic FDA data

Cephalexin

Product NDC
50090-3111
11-digit product format
500903111
Labeler code
50090
Product ID
50090-3111_4b2dc701-2bfd-4330-8c32-666e1e08cbb7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065229
Marketing category
ANDA
Marketing start
2006-01-11
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
50090-3111-12023-01-30C16284748780-1f386c64a-41cd-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES USP safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES USP CEPHALEXIN capsules USP, for oral use Initial U.S. Approval: 1971

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3111-1Cephalexin12 in 1 BOTTLECAPSULE123

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3111-1EA - Each50090-311118db7b15-e5ab-43a4-af17-858450c27afd12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3111CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS]3Legacy NDC, 1 package rows20200121_86fe2a70-3e02-4d43-8d96-d47d4895388a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSN86fe2a70-3e02-4d43-8d96-d47d4895388a3
309114cephalexin 500 MG Oral CapsuleSCD86fe2a70-3e02-4d43-8d96-d47d4895388a3
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY86fe2a70-3e02-4d43-8d96-d47d4895388a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3111-15009031110112 CAPSULE in 1 BOTTLE (50090-3111-1) 12 capsule2017-08-010000-00-00NoNoCurrent