FDA.reportPublic FDA data

Primidone

Product NDC
53746-544
11-digit product format
537460544
Labeler code
53746
Product ID
53746-544_574c0bff-04c5-41f0-8d10-315a824d8efd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Primidone
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA040866
Marketing category
ANDA
Marketing start
2009-12-24
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
53746-544-01Primidone100 in 1 BOTTLETABLET10011
53746-544-05Primidone500 in 1 BOTTLETABLET50011
53746-544-10Primidone1000 in 1 BOTTLETABLET100011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53746-544-01EA - Each53746-5445a840369-eb34-482f-9ea2-e4b63c088db012017-09-11
53746-544-05EA - Each53746-5448940b17e-b9d8-4c75-a960-fe9b9123d9f312017-09-11

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
53746-544PRIMIDONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]10Current NDC, Legacy NDC, 3 package rows20240101_3cdc361a-5558-4341-ad40-f8bc29b4f1ce.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
96304primidone 250 MG Oral TabletPSN3cdc361a-5558-4341-ad40-f8bc29b4f1ce11
198150primidone 50 MG Oral TabletPSN3cdc361a-5558-4341-ad40-f8bc29b4f1ce11
96304primidone 250 MG Oral TabletSCD3cdc361a-5558-4341-ad40-f8bc29b4f1ce11
198150primidone 50 MG Oral TabletSCD3cdc361a-5558-4341-ad40-f8bc29b4f1ce11
198150primidone 50 MG Oral TabletPSN93b4b34c-6dba-4aec-b98e-b2b18feb86a95
198150primidone 50 MG Oral TabletSCD93b4b34c-6dba-4aec-b98e-b2b18feb86a95
198150primidone 50 MG Oral TabletPSN1c56d09c-4224-4875-bb22-e8bfd595d3783
198150primidone 50 MG Oral TabletSCD1c56d09c-4224-4875-bb22-e8bfd595d3783

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53746-544-0153746054401100 TABLET in 1 BOTTLE (53746-544-01) 100 tablet2009-12-240000-00-00NoNoCurrent
53746-544-0553746054405500 TABLET in 1 BOTTLE (53746-544-05) 500 tablet2009-12-240000-00-00NoNoCurrent
53746-544-10537460544101000 TABLET in 1 BOTTLE (53746-544-10) 1000 tablet2009-12-240000-00-00NoNoCurrent