FDA.reportPublic FDA data

CEPHALEXIN

Product NDC
61919-522
11-digit product format
619190522
Labeler code
61919
Product ID
61919-522_9c5b1895-9496-84b7-e053-2995a90a9940
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEPHALEXIN
Dosage form
CAPSULE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA062713
Marketing category
ANDA
Marketing start
2016-02-09
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
61919-522-302023-01-30C16284748780-1d6a99b39-a0d7-a426-e053-dadaa90af4c2CEPHALEXIN 500 mg
61919-522-302022-01-28C16284748780-1d6a99b39-a0d7-a426-e053-dadaa90af4c2CEPHALEXIN 500 mg
61919-522-202020-01-31C16284748780-19d75b9d0-ac66-f424-e053-dadaa90a57ceCEPHALEXIN
61919-522-402020-01-31C16284748780-19d75b9d0-ac66-f424-e053-dadaa90a57ceCEPHALEXIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-522-30CEPHALEXIN1 in 1 BOTTLECAPSULE14
61919-522-20CEPHALEXIN20 in 1 BOTTLECAPSULE202
61919-522-40CEPHALEXIN40 in 1 BOTTLECAPSULE402

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-522-20EA - Each61919-5223caf1806-9836-4921-ad60-4002ea43336212016-06-14
61919-522-30EA - Each61919-522aa36fad5-8804-482a-ae84-c004c42d502212019-04-11
61919-522-40EA - Each61919-522edc9f5ee-7efa-44b2-8063-1f534aca338d12016-06-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
cephalexinACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [DIRECTRX]2
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [DIRECTRX]2
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKCEPHALEXIN CAPSULE [DIRECTRX]2
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357CEPHALEXIN CAPSULE [DIRECTRX]2
gelatinINACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [DIRECTRX]2
magnesium stearateINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [DIRECTRX]2
talcINACTIVE INGREDIENT7SEV7J4R1UCEPHALEXIN CAPSULE [DIRECTRX]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [DIRECTRX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-522CEPHALEXIN CAPSULE [DIRECT RX]3Legacy NDC, 1 package rows20200129_2d12e6a9-f7dd-25ed-e054-00144ff8d46c.zip
61919-522CEPHALEXIN CAPSULE [DIRECTRX]2Legacy NDC, 2 package rows20151110_2081f146-534f-4bc6-ab56-448bf9a9a81a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSN2d12e6a9-f7dd-25ed-e054-00144ff8d46c4
309114cephalexin 500 MG Oral CapsuleSCD2d12e6a9-f7dd-25ed-e054-00144ff8d46c4
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY2d12e6a9-f7dd-25ed-e054-00144ff8d46c4
309114cephalexin 500 MG Oral CapsulePSN2081f146-534f-4bc6-ab56-448bf9a9a81a2
309114cephalexin 500 MG Oral CapsuleSCD2081f146-534f-4bc6-ab56-448bf9a9a81a2
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY2081f146-534f-4bc6-ab56-448bf9a9a81a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-522-206191905222020 in 1 BOTTLEHistorical
61919-522-30619190522301 CAPSULE in 1 BOTTLE (61919-522-30) 1 capsule2016-02-090000-00-00NoNoCurrent
61919-522-406191905224040 in 1 BOTTLEHistorical