FDA.reportPublic FDA data

Biltricide

Product NDC
76413-146
11-digit product format
764130146
Labeler code
76413
Product ID
76413-146_f4b54a8c-fefe-4290-bd07-3d13b4699730
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
praziquantel
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Central Texas Community Health Centers
Application
NDA018714
Marketing category
NDA
Marketing start
2011-04-21
Marketing end
0000-00-00
Substance
PRAZIQUANTEL
Active strength
600 mg/1
Pharmacologic classes
Anthelmintic [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8cabd598-669e-43ab-9753-4aec00a484cbProduct name120180125

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76413-146-012020-01-31C16284748780-19d75b9d0-0916-f424-e053-dadaa90a57ceBILTRICIDE ® TABLETS (praziquantel)
76413-146-022020-01-31C16284748780-19d75b9d0-0916-f424-e053-dadaa90a57ceBILTRICIDE ® TABLETS (praziquantel)
76413-146-032020-01-31C16284748780-19d75b9d0-0916-f424-e053-dadaa90a57ceBILTRICIDE ® TABLETS (praziquantel)
76413-146-042020-01-31C16284748780-19d75b9d0-0916-f424-e053-dadaa90a57ceBILTRICIDE ® TABLETS (praziquantel)
76413-146-052020-01-31C16284748780-19d75b9d0-0916-f424-e053-dadaa90a57ceBILTRICIDE ® TABLETS (praziquantel)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76413-146-01Biltricide1 in 1 BOTTLETABLET, FILM COATED11
76413-146-02Biltricide2 in 1 BOTTLETABLET, FILM COATED21
76413-146-03Biltricide3 in 1 BOTTLETABLET, FILM COATED31
76413-146-04Biltricide4 in 1 BOTTLETABLET, FILM COATED41
76413-146-05Biltricide5 in 1 BOTTLETABLET, FILM COATED51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76413-146BILTRICIDE (PRAZIQUANTEL) TABLET, FILM COATED [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]1Legacy NDC, 5 package rows20170824_d6791c7c-749a-4595-937b-32229dd59902.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
208975Biltricide Tablets 600 MG Oral TabletPSNd6791c7c-749a-4595-937b-32229dd599021
198140praziquantel 600 MG Oral TabletPSNd6791c7c-749a-4595-937b-32229dd599021
208975praziquantel 600 MG Oral Tablet [Biltricide]SBDd6791c7c-749a-4595-937b-32229dd599021
198140praziquantel 600 MG Oral TabletSCDd6791c7c-749a-4595-937b-32229dd599021
208975Biltricide 600 MG Oral TabletSYd6791c7c-749a-4595-937b-32229dd599021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
76413-146-01764130146011 in 1 BOTTLEHistorical
76413-146-02764130146022 in 1 BOTTLEHistorical
76413-146-03764130146033 in 1 BOTTLEHistorical
76413-146-04764130146044 in 1 BOTTLEHistorical
76413-146-05764130146055 in 1 BOTTLEHistorical