FDA.reportPublic FDA data

Primidone

Product NDC
80005-117
11-digit product format
800050117
Labeler code
80005
Product ID
80005-117_1f77f842-e0b6-4659-beee-0bb01da839e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Primidone
Dosage form
TABLET
Route
ORAL
Labeler
Carnegie Pharmaceuticals LLC
Application
ANDA218366
Marketing category
ANDA
Marketing start
2024-05-01
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
80005-117-11Primidone100 in 1 BOTTLETABLET1004
80005-117-14Primidone500 in 1 BOTTLETABLET5004
80005-117-15Primidone1000 in 1 BOTTLETABLET10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80005-117-11EA - Each80005-11723ecfaf7-4d35-44f4-80d6-e942409f668a12024-10-04
80005-117-14EA - Each80005-117b20c420c-d617-4732-bc7b-cc0c5ffde20e12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80005-117PRIMIDONE TABLET [CARNEGIE PHARMACEUTICALS LLC]4Current NDC, 3 package rows20240704_dc018b1d-72d3-45a2-84ff-cf9499c7ae97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
96304primidone 250 MG Oral TabletPSNdc018b1d-72d3-45a2-84ff-cf9499c7ae974
198150primidone 50 MG Oral TabletPSNdc018b1d-72d3-45a2-84ff-cf9499c7ae974
96304primidone 250 MG Oral TabletSCDdc018b1d-72d3-45a2-84ff-cf9499c7ae974
198150primidone 50 MG Oral TabletSCDdc018b1d-72d3-45a2-84ff-cf9499c7ae974

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80005-117-1180005011711100 TABLET in 1 BOTTLE (80005-117-11) 100 tablet2024-05-01NoNoCurrent
80005-117-1480005011714500 TABLET in 1 BOTTLE (80005-117-14) 500 tablet2024-05-01NoNoCurrent
80005-117-15800050117151000 TABLET in 1 BOTTLE (80005-117-15) 1000 tablet2024-05-01NoNoCurrent