FDA.reportPublic FDA data

Primidone

Product NDC
50268-686
11-digit product format
502680686
Labeler code
50268
Product ID
50268-686_42dc4ff9-003f-d362-e063-6394a90ad6f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Primidone
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA040866
Marketing category
ANDA
Marketing start
2011-05-19
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
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
50268-686-11Primidone1 in 1 BLISTER PACKTABLET114
50268-686-15Primidone50 in 1 BOX, UNIT-DOSETABLET5014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-686-11EA - Each50268-686d4dcc5e3-8951-4f17-a249-11bcaca7717e12015-05-05
50268-686-15EA - Each50268-686626a5d2a-b4d6-42c7-a558-2ce1de6e672012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRIMIDONEACTIVE INGREDIENT13AFD7670QPRIMIDONE TABLET [AVPAK]8
PRIMIDONEACTIVE MOIETY13AFD7670QPRIMIDONE TABLET [AVPAK]8
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UPRIMIDONE TABLET [AVPAK]8
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XPRIMIDONE TABLET [AVPAK]8
Magnesium StearateINACTIVE INGREDIENT70097M6I30PRIMIDONE TABLET [AVPAK]8
Methylcellulose (100 Cps)INACTIVE INGREDIENT4GFU244C4JPRIMIDONE TABLET [AVPAK]8
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JPRIMIDONE TABLET [AVPAK]8
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A2PRIMIDONE TABLET [AVPAK]8
Starch, CornINACTIVE INGREDIENTO8232NY3SJPRIMIDONE TABLET [AVPAK]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-686PRIMIDONE TABLET [AVPAK]12Current NDC, Legacy NDC, 2 package rows20240110_a90d5ba6-4170-0b97-5ae3-fc707c9e4f1b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
96304primidone 250 MG Oral TabletPSNa90d5ba6-4170-0b97-5ae3-fc707c9e4f1b14
198150primidone 50 MG Oral TabletPSNa90d5ba6-4170-0b97-5ae3-fc707c9e4f1b14
96304primidone 250 MG Oral TabletSCDa90d5ba6-4170-0b97-5ae3-fc707c9e4f1b14
198150primidone 50 MG Oral TabletSCDa90d5ba6-4170-0b97-5ae3-fc707c9e4f1b14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-686-11502680686111 in 1 BLISTER PACKHistorical
50268-686-155026806861550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-686-15) / 1 TABLET in 1 BLISTER PACK (50268-686-11) 50 blister pack2011-05-190000-00-00NoNoCurrent