FDA.reportPublic FDA data

Primidone

Product NDC
82804-952
11-digit product format
828040952
Labeler code
82804
Product ID
82804-952_db761e34-8573-4f96-872c-e851b3004e5e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Primidone
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Primidone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRIMIDONE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii13AFD7670Q
Rxcui96304, 198150

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
82804-952-00Primidone100 in 1 BOTTLE, PLASTICTABLET1001
82804-952-11Primidone1000 in 1 BOTTLE, PLASTICTABLET10001
82804-952-30Primidone30 in 1 BOTTLE, PLASTICTABLET301
82804-952-55Primidone500 in 1 BOTTLE, PLASTICTABLET5001
82804-952-60Primidone60 in 1 BOTTLE, PLASTICTABLET601
82804-952-72Primidone120 in 1 BOTTLE, PLASTICTABLET1201
82804-952-90Primidone90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-952-00EA - Each82804-952686c8dfd-173b-4907-a8a5-9543c41c859a12026-03-17
82804-952-11EA - Each82804-9528c40c1cc-922b-4e0f-bdab-8a4130c9342212026-03-17
82804-952-30EA - Each82804-952540d7196-ed67-4b28-825f-d9813434059612026-03-17
82804-952-55EA - Each82804-95205e41034-f7ee-4b0a-bdf6-a5a82ce5558112026-03-17
82804-952-60EA - Each82804-952c3103a27-d358-46d4-a899-f05e6d991d9312026-03-17
82804-952-72EA - Each82804-9528e420c9b-320c-4b9c-bf11-4154bdd50a4a12026-03-17
82804-952-90EA - Each82804-9520df55c93-67cb-43e3-b5c1-6f5170158d7712026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
96304primidone 250 MG Oral TabletPSNdb761e34-8573-4f96-872c-e851b3004e5e1
198150primidone 50 MG Oral TabletPSNdb761e34-8573-4f96-872c-e851b3004e5e1
96304primidone 250 MG Oral TabletSCDdb761e34-8573-4f96-872c-e851b3004e5e1
198150primidone 50 MG Oral TabletSCDdb761e34-8573-4f96-872c-e851b3004e5e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-952-0082804095200100 TABLET in 1 BOTTLE, PLASTIC (82804-952-00) 100 tablet2026-01-12NoNoHistorical
82804-952-11828040952111000 TABLET in 1 BOTTLE, PLASTIC (82804-952-11) 1000 tablet2026-01-12NoNoHistorical
82804-952-308280409523030 TABLET in 1 BOTTLE, PLASTIC (82804-952-30) 30 tablet2026-01-12NoNoHistorical
82804-952-5582804095255500 TABLET in 1 BOTTLE, PLASTIC (82804-952-55) 500 tablet2026-01-12NoNoHistorical
82804-952-608280409526060 TABLET in 1 BOTTLE, PLASTIC (82804-952-60) 60 tablet2026-01-12NoNoHistorical
82804-952-7282804095272120 TABLET in 1 BOTTLE, PLASTIC (82804-952-72) 120 tablet2026-01-12NoNoHistorical
82804-952-908280409529090 TABLET in 1 BOTTLE, PLASTIC (82804-952-90) 90 tablet2026-01-12NoNoHistorical