Primidone

Product NDC
50090-1622
11-digit product format
500901622
Labeler code
50090
Product ID
50090-1622_cf855792-6337-4f0a-8f7f-caae1ace7f21
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Primidone
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA083551
Marketing category
ANDA
Marketing start
2010-06-19
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

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
50090-1622-02023-01-30C16284748780-1f386c649-9f28-0266-e053-dadaa90a7c1aPrimidone Tablets, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1622-0Primidone100 in 1 BOTTLETABLET1007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1622PRIMIDONE TABLET [A-S MEDICATION SOLUTIONS]7Legacy NDC, 1 package rows20210811_c5d3d4d4-982e-4fbd-8b03-2edd52989dc1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
96304primidone 250 MG Oral TabletPSNc5d3d4d4-982e-4fbd-8b03-2edd52989dc17
96304primidone 250 MG Oral TabletSCDc5d3d4d4-982e-4fbd-8b03-2edd52989dc17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1622-050090162200100 TABLET in 1 BOTTLE (50090-1622-0) 100 tablet2015-01-120000-00-00NoNoCurrent