FDA.reportPublic FDA data

Primidone

Product NDC
63629-7811
11-digit product format
636297811
Labeler code
63629
Product ID
63629-7811_53cadff5-416c-4786-aafe-edf62e11941a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Primidone
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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
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
Rxcui198150

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a6e0ba9-1dda-c47a-a8e3-5844e445a4f8Product name320250114

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-7811-12020-10-16C16284748780-19d75b9d0-7546-f424-e053-dadaa90a57cePrimidone Tablets, USP (50 mg and 250 mg) Rx only
63629-7811-12020-01-31C16284748780-19d75b9d0-7546-f424-e053-dadaa90a57cePrimidone Tablets, USP (50 mg and 250 mg) Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-7811-1Primidone30 in 1 BOTTLETABLET305
63629-7811-2Primidone90 in 1 BOTTLETABLET905
63629-7811-3Primidone60 in 1 BOTTLETABLET605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7811PRIMIDONE TABLET [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 3 package rows20240502_93b4b34c-6dba-4aec-b98e-b2b18feb86a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198150primidone 50 MG Oral TabletPSN93b4b34c-6dba-4aec-b98e-b2b18feb86a95
198150primidone 50 MG Oral TabletSCD93b4b34c-6dba-4aec-b98e-b2b18feb86a95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7811-16362978110130 TABLET in 1 BOTTLE (63629-7811-1) 30 tablet2018-10-230000-00-00NoNoCurrent
63629-7811-26362978110290 TABLET in 1 BOTTLE (63629-7811-2) 90 tablet2019-03-190000-00-00NoNoCurrent
63629-7811-36362978110360 TABLET in 1 BOTTLE (63629-7811-3) 60 tablet2024-04-030000-00-00NoNoCurrent