FDA.reportPublic FDA data

Cephalexin

Product NDC
50436-2210
11-digit product format
504362210
Labeler code
50436
Product ID
50436-2210_9be4b3c9-0881-4a4b-9199-9d0307837b46
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Unit Dose Services
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
2020-12-31
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
50436-2210-12021-01-29C16284748780-1ba0f9c33-2cb2-a910-e053-dadaa90a0b85HIGHLIGHTS OF PRESCRIBING INFORMATION These 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
50436-2210-22021-01-29C16284748780-1ba0f9c33-2cb2-a910-e053-dadaa90a0b85HIGHLIGHTS OF PRESCRIBING INFORMATION These 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
50436-2210-42021-01-29C16284748780-1ba0f9c33-2cb2-a910-e053-dadaa90a0b85HIGHLIGHTS OF PRESCRIBING INFORMATION These 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
50436-2210-52021-01-29C16284748780-1ba0f9c33-2cb2-a910-e053-dadaa90a0b85HIGHLIGHTS OF PRESCRIBING INFORMATION These 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
50436-2210-1Cephalexin30 in 1 BOTTLECAPSULE303
50436-2210-2Cephalexin20 in 1 BOTTLECAPSULE203
50436-2210-4Cephalexin28 in 1 BOTTLECAPSULE283
50436-2210-5Cephalexin40 in 1 BOTTLECAPSULE403

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-2210-1EA - Each50436-2210648ef9ce-cb0b-47b2-9b2d-03655a81a54e12017-09-11
50436-2210-2EA - Each50436-221068e7d2f4-1ef2-42f7-baa7-eaf3eac0f9e912017-09-11
50436-2210-4EA - Each50436-2210426ff4af-c50f-4437-b27d-77e225768fda12017-09-11
50436-2210-5EA - Each50436-2210f7906a8d-273b-4ef2-a078-94daef047f3012017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-2210CEPHALEXIN CAPSULE [UNIT DOSE SERVICES]3Legacy NDC, 4 package rows20170821_ffead704-cd5f-489f-bf32-108a42b47606.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSNffead704-cd5f-489f-bf32-108a42b476063
309114cephalexin 500 MG Oral CapsuleSCDffead704-cd5f-489f-bf32-108a42b476063
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYffead704-cd5f-489f-bf32-108a42b476063

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-2210-15043622100130 in 1 BOTTLEHistorical
50436-2210-25043622100220 in 1 BOTTLEHistorical
50436-2210-45043622100428 in 1 BOTTLEHistorical
50436-2210-55043622100540 in 1 BOTTLEHistorical