FDA.reportPublic FDA data

Primidone

Product NDC
0527-1231
11-digit product format
005271231
Labeler code
0527
Product ID
0527-1231_99bd0a67-2742-43dd-9ddc-430b9141c3b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Primidone
Dosage form
TABLET
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA084903
Marketing category
ANDA
Marketing start
1978-12-01
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
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
PRIMIDONE250 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0527-1231-012024-01-30C16284748780-11030e365-2f3e-111a-e063-dadaa90a10e2Primidone Tablets, USP
0527-1231-052024-01-30C16284748780-11030e365-2f3e-111a-e063-dadaa90a10e2Primidone Tablets, USP
0527-1231-102024-01-30C16284748780-11030e365-2f3e-111a-e063-dadaa90a10e2Primidone Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0527-1231-01Primidone100 in 1 BOTTLETABLET10014
0527-1231-05Primidone500 in 1 BOTTLETABLET50014
0527-1231-10Primidone1000 in 1 BOTTLETABLET100014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-1231PRIMIDONE TABLET [LANNETT COMPANY, INC.]14Current NDC, Legacy NDC, 3 package rows20240704_a1a817f7-c190-4825-94eb-442f477187e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
96304primidone 250 MG Oral TabletPSNa1a817f7-c190-4825-94eb-442f477187e314
198150primidone 50 MG Oral TabletPSNa1a817f7-c190-4825-94eb-442f477187e314
96304primidone 250 MG Oral TabletSCDa1a817f7-c190-4825-94eb-442f477187e314
198150primidone 50 MG Oral TabletSCDa1a817f7-c190-4825-94eb-442f477187e314
96304primidone 250 MG Oral TabletPSNa32e0a00-3ba7-47e7-83c6-a7eac5fbdd1111
198150primidone 50 MG Oral TabletPSNa32e0a00-3ba7-47e7-83c6-a7eac5fbdd1111
96304primidone 250 MG Oral TabletSCDa32e0a00-3ba7-47e7-83c6-a7eac5fbdd1111
198150primidone 50 MG Oral TabletSCDa32e0a00-3ba7-47e7-83c6-a7eac5fbdd1111
96304primidone 250 MG Oral TabletPSNc7cb2073-9d44-4261-b308-02cd24c1f17a9
198150primidone 50 MG Oral TabletPSNc7cb2073-9d44-4261-b308-02cd24c1f17a9
96304primidone 250 MG Oral TabletSCDc7cb2073-9d44-4261-b308-02cd24c1f17a9
198150primidone 50 MG Oral TabletSCDc7cb2073-9d44-4261-b308-02cd24c1f17a9
96304primidone 250 MG Oral TabletPSNe4e493bd-94d7-7e5a-e053-2995a90a27062
198150primidone 50 MG Oral TabletPSNe4e493bd-94d7-7e5a-e053-2995a90a27062
96304primidone 250 MG Oral TabletSCDe4e493bd-94d7-7e5a-e053-2995a90a27062
198150primidone 50 MG Oral TabletSCDe4e493bd-94d7-7e5a-e053-2995a90a27062

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-1231-0100527123101100 TABLET in 1 BOTTLE (0527-1231-01) 100 tablet1978-12-010000-00-00NoNoCurrent
0527-1231-0500527123105500 TABLET in 1 BOTTLE (0527-1231-05) 500 tablet1978-12-010000-00-00NoNoCurrent
0527-1231-10005271231101000 TABLET in 1 BOTTLE (0527-1231-10) 1000 tablet1978-12-010000-00-00NoNoCurrent