FDA.reportPublic FDA data

CEPHALEXIN

Product NDC
61919-029
11-digit product format
619190029
Labeler code
61919
Product ID
61919-029_bf8cdb90-b894-4037-92b4-cb65a5504fa7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEPHALEXIN
Dosage form
CAPSULE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA062713
Marketing category
ANDA
Marketing start
2015-01-01
Marketing end
0000-00-00
Substance
CEPHALEXIN
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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
61919-029-102020-01-31C16284748780-19d75b9d0-fe35-f424-e053-dadaa90a57ceCEPHALEXIN
61919-029-142020-01-31C16284748780-19d75b9d0-fe35-f424-e053-dadaa90a57ceCEPHALEXIN
61919-029-202020-01-31C16284748780-19d75b9d0-fe35-f424-e053-dadaa90a57ceCEPHALEXIN
61919-029-282020-01-31C16284748780-19d75b9d0-fe35-f424-e053-dadaa90a57ceCEPHALEXIN
61919-029-302020-01-31C16284748780-19d75b9d0-fe35-f424-e053-dadaa90a57ceCEPHALEXIN
61919-029-402020-01-31C16284748780-19d75b9d0-fe35-f424-e053-dadaa90a57ceCEPHALEXIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-029-10CEPHALEXIN10 in 1 BOTTLECAPSULE106
61919-029-14CEPHALEXIN14 in 1 BOTTLECAPSULE146
61919-029-20CEPHALEXIN20 in 1 BOTTLECAPSULE206
61919-029-28CEPHALEXIN28 in 1 BOTTLECAPSULE286
61919-029-30CEPHALEXIN30 in 1 BOTTLECAPSULE306
61919-029-40CEPHALEXIN40 in 1 BOTTLECAPSULE406

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-029-10EA - Each61919-029d3da6fba-69cf-458a-87f0-fb1cdf2ceae512016-06-14
61919-029-20EA - Each61919-0294b90a2a7-1424-4be8-bf7a-32f6972bba4912018-09-05
61919-029-28EA - Each61919-02978fdaec4-899c-441b-832e-df8d3310b7b812016-06-14
61919-029-30EA - Each61919-029b763df8d-ebaf-4c84-a50d-79487a955db812015-10-02
61919-029-40EA - Each61919-029306b09fe-d8ad-4c10-b906-41a577edb2bb12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [DIRECT RX]6
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [DIRECT RX]6
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCEPHALEXIN CAPSULE [DIRECT RX]6
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [DIRECT RX]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [DIRECT RX]6
TALCINACTIVE INGREDIENT7SEV7J4R1UCEPHALEXIN CAPSULE [DIRECT RX]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [DIRECT RX]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-029CEPHALEXIN CAPSULE [DIRECT RX]6Legacy NDC, 6 package rows20150810_affbe20a-5339-4062-bc0a-a53dcd50261a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSNaffbe20a-5339-4062-bc0a-a53dcd50261a6
309114cephalexin 500 MG Oral CapsuleSCDaffbe20a-5339-4062-bc0a-a53dcd50261a6
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYaffbe20a-5339-4062-bc0a-a53dcd50261a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-029-106191900291010 in 1 BOTTLEHistorical
61919-029-146191900291414 in 1 BOTTLEHistorical
61919-029-206191900292020 in 1 BOTTLEHistorical
61919-029-286191900292828 in 1 BOTTLEHistorical
61919-029-306191900293030 in 1 BOTTLEHistorical
61919-029-406191900294040 in 1 BOTTLEHistorical