Primidone

Product NDC
68084-202
11-digit product format
680840202
Labeler code
68084
Product ID
68084-202_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
2007-09-05
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
68084-202-01Primidone100 in 1 BOX, UNIT-DOSETABLET10011
68084-202-11Primidone1 in 1 BLISTER PACKTABLET111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-202-01EA - Each68084-202d6667e7a-52a3-4f32-a547-bf99d3ec7e2112012-07-24
68084-202-11EA - Each68084-202334e5c6a-3b8d-43af-8191-50bca1c87c8112012-07-24

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
68084-202PRIMIDONE 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
68084-202-0168084020201100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-202-01) / 1 TABLET in 1 BLISTER PACK (68084-202-11) 100 blister pack2007-09-050000-00-00NoNoCurrent
68084-202-11680840202111 in 1 BLISTER PACKHistorical