FDA.reportPublic FDA data

Primidone

Product NDC
71610-540
11-digit product format
716100540
Labeler code
71610
Product ID
71610-540_11c79cec-987d-4bce-b8ce-ba3edbe60dc6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Primidone
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA040586
Marketing category
ANDA
Marketing start
2021-02-22
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Primidone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRIMIDONE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii13AFD7670Q
Rxcui198150

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-540-09Primidone9000 in 1 BOTTLE, PLASTICTABLET90003
71610-540-60Primidone90 in 1 BOTTLE, PLASTICTABLET903
71610-540-80Primidone180 in 1 BOTTLE, PLASTICTABLET1803
71610-540-92Primidone270 in 1 BOTTLE, PLASTICTABLET2703
71610-540-94Primidone360 in 1 BOTTLE, PLASTICTABLET3603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-540-09EA - Each71610-540a7a29e78-b144-4e9d-80c1-f38d96277de312021-09-07
71610-540-60EA - Each71610-540237a5b61-af16-40e3-b8a1-deca7f7aef1a12021-07-15
71610-540-80EA - Each71610-540e2704eb9-a325-4dde-beb8-1fd28378ae9112021-07-15
71610-540-92EA - Each71610-540ed44dc86-dd3a-4e2e-96ec-9e44a8025de412021-07-15
71610-540-94EA - Each71610-540a97fff61-6191-4a52-af64-82f757374d2112021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-540PRIMIDONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Current NDC, Legacy NDC, 5 package rows20211016_91de277e-34b8-4ee1-8846-f02aea626089.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198150primidone 50 MG Oral TabletPSN91de277e-34b8-4ee1-8846-f02aea6260893
198150primidone 50 MG Oral TabletSCD91de277e-34b8-4ee1-8846-f02aea6260893

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-540-09716100540099000 TABLET in 1 BOTTLE, PLASTIC (71610-540-09) 9000 tablet2021-06-280000-00-00NoNoCurrent
71610-540-607161005406090 TABLET in 1 BOTTLE, PLASTIC (71610-540-60) 90 tablet2021-04-060000-00-00NoNoCurrent
71610-540-8071610054080180 TABLET in 1 BOTTLE, PLASTIC (71610-540-80) 180 tablet2021-04-060000-00-00NoNoCurrent
71610-540-9271610054092270 TABLET in 1 BOTTLE, PLASTIC (71610-540-92) 270 tablet2021-04-060000-00-00NoNoCurrent
71610-540-9471610054094360 TABLET in 1 BOTTLE, PLASTIC (71610-540-94) 360 tablet2021-09-200000-00-00NoNoCurrent