Primidone

Product NDC
71335-1158
11-digit product format
713351158
Labeler code
71335
Product ID
71335-1158_1414ad7c-26e8-43f6-b211-d102eba1d1c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Primidone
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA084903
Marketing category
ANDA
Marketing start
2001-05-24
Marketing end
0000-00-00
Substance
PRIMIDONE
Active strength
50 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a6e0ba9-1dda-c47a-a8e3-5844e445a4f8Product name320250114

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1158-12024-01-30C16284748780-11030e365-38c7-111a-e063-dadaa90a10e2Primidone Tablets, USP
71335-1158-22024-01-30C16284748780-11030e365-38c7-111a-e063-dadaa90a10e2Primidone Tablets, USP
71335-1158-32024-01-30C16284748780-11030e365-38c7-111a-e063-dadaa90a10e2Primidone Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1158-1Primidone30 in 1 BOTTLETABLET304
71335-1158-2Primidone90 in 1 BOTTLETABLET904
71335-1158-3Primidone60 in 1 BOTTLETABLET604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1158PRIMIDONE TABLET [BRYANT RANCH PREPACK]4Legacy NDC, 3 package rows20220204_1414ad7c-26e8-43f6-b211-d102eba1d1c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198150primidone 50 MG Oral TabletPSN1414ad7c-26e8-43f6-b211-d102eba1d1c44
198150primidone 50 MG Oral TabletSCD1414ad7c-26e8-43f6-b211-d102eba1d1c44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1158-17133511580130 TABLET in 1 BOTTLE (71335-1158-1) 30 tablet2021-12-280000-00-00NoNoCurrent
71335-1158-27133511580290 TABLET in 1 BOTTLE (71335-1158-2) 90 tablet2019-03-190000-00-00NoNoCurrent
71335-1158-37133511580360 TABLET in 1 BOTTLE (71335-1158-3) 60 tablet2019-06-260000-00-00NoNoCurrent