CEPHALEXIN

Product NDC
61919-035
11-digit product format
619190035
Labeler code
61919
Product ID
61919-035_9c5b16e4-069f-b82d-e053-2a95a90a691a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEPHALEXIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA065248
Marketing category
ANDA
Marketing start
2019-08-14
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
61919-035-102022-01-28C16284748780-1d6a99b39-51d1-a426-e053-dadaa90af4c2CEPHALEXIN
61919-035-302020-01-31C16284748780-19d75b9d0-54e2-f424-e053-dadaa90a57ceCEPHALEXIN
61919-035-402020-01-31C16284748780-19d75b9d0-54e2-f424-e053-dadaa90a57ceCEPHALEXIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-035-10CEPHALEXIN10 in 1 BOTTLECAPSULE102
61919-035-30CEPHALEXIN30 in 1 BOTTLECAPSULE302
61919-035-40CEPHALEXIN40 in 1 BOTTLECAPSULE402

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-035-10EA - Each61919-0351ba0de70-9424-4f27-9af4-813a1bc254cb12019-09-05
61919-035-30EA - Each61919-035f50ba949-bb2c-4509-87a3-ec5043a7e34b12017-04-05
61919-035-40EA - Each61919-035baef983c-a5a4-46ba-8e19-87a64dd49d9212017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-035CEPHALEXIN CAPSULE [DIRECT RX]2Legacy NDC, 2 package rows20170310_48fc82b4-f05c-267f-e054-00144ff8d46c.zip
61919-035CEPHALEXIN CAPSULE [DIRECT_RX]2Legacy NDC, 1 package rows20200118_9014d5c3-9de3-3f9f-e053-2a95a90a45c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSN48fc82b4-f05c-267f-e054-00144ff8d46c2
309114cephalexin 500 MG Oral CapsulePSN9014d5c3-9de3-3f9f-e053-2a95a90a45c12
309114cephalexin 500 MG Oral CapsuleSCD48fc82b4-f05c-267f-e054-00144ff8d46c2
309114cephalexin 500 MG Oral CapsuleSCD9014d5c3-9de3-3f9f-e053-2a95a90a45c12
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY48fc82b4-f05c-267f-e054-00144ff8d46c2
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY9014d5c3-9de3-3f9f-e053-2a95a90a45c12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-035-106191900351010 CAPSULE in 1 BOTTLE (61919-035-10) 10 capsule2019-08-140000-00-00NoNoCurrent
61919-035-306191900353030 in 1 BOTTLEHistorical
61919-035-406191900354040 in 1 BOTTLEHistorical