Primidone

Product NDC
68084-203
11-digit product format
680840203
Labeler code
68084
Product ID
68084-203_23950268-33a3-8f1e-e063-6394a90a736a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Primidone
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA084903
Marketing category
ANDA
Marketing start
2007-09-17
Substance
PRIMIDONE
Active strength
250 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
PRIMIDONE250 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
68084-203-01Primidone100 in 1 BOX, UNIT-DOSETABLET10011
68084-203-11Primidone1 in 1 BLISTER PACKTABLET111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-203-01EA - Each68084-2031d1ca8ea-291e-4ef0-bc80-894a4ac837de12012-07-24
68084-203-11EA - Each68084-20362bb6734-fc38-4abc-a9ba-928607015f0912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRIMIDONEACTIVE INGREDIENT13AFD7670QPRIMIDONE TABLET [AMERICAN HEALTH PACKAGING]2
PRIMIDONEACTIVE MOIETY13AFD7670QPRIMIDONE TABLET [AMERICAN HEALTH PACKAGING]2
ACACIAINACTIVE INGREDIENT5C5403N26OPRIMIDONE TABLET [AMERICAN HEALTH PACKAGING]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPRIMIDONE TABLET [AMERICAN HEALTH PACKAGING]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRIMIDONE TABLET [AMERICAN HEALTH PACKAGING]2
METHYLCELLULOSE (400 MPA.S)INACTIVE INGREDIENTO0GN6F9B2YPRIMIDONE TABLET [AMERICAN HEALTH PACKAGING]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PRIMIDONE TABLET [AMERICAN HEALTH PACKAGING]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-203PRIMIDONE TABLET [AMERICAN HEALTH PACKAGING]11Current NDC, Legacy NDC, 2 package rows20241004_a32e0a00-3ba7-47e7-83c6-a7eac5fbdd11.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
96304primidone 250 MG Oral TabletPSNa32e0a00-3ba7-47e7-83c6-a7eac5fbdd1111
198150primidone 50 MG Oral TabletPSNa32e0a00-3ba7-47e7-83c6-a7eac5fbdd1111
96304primidone 250 MG Oral TabletSCDa32e0a00-3ba7-47e7-83c6-a7eac5fbdd1111
198150primidone 50 MG Oral TabletSCDa32e0a00-3ba7-47e7-83c6-a7eac5fbdd1111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-203-0168084020301100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-203-01) / 1 TABLET in 1 BLISTER PACK (68084-203-11) 100 blister pack2007-09-170000-00-00NoNoCurrent
68084-203-11680840203111 in 1 BLISTER PACKHistorical