Primidone

Product NDC
71610-191
11-digit product format
716100191
Labeler code
71610
Product ID
71610-191_5342e071-7b2f-4231-a73d-8c227f928494
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Primidone
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA084903
Marketing category
ANDA
Marketing start
2005-04-07
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-191-60EA - Each71610-19122562b5f-cd70-4e63-a1e2-9f25b34a75f712019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-191PRIMIDONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC20190109_fe761fa9-d97c-4ef4-a816-96e237c8749c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-191-607161001916090 TABLET in 1 BOTTLE (71610-191-60) 90 tablet2018-11-090000-00-00NoNoCurrent