Primidone

Product NDC
51407-637
11-digit product format
514070637
Labeler code
51407
Product ID
51407-637_29f49f7f-d100-e0e1-e063-6394a90ac981
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Primidone
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc
Application
ANDA084903
Marketing category
ANDA
Marketing start
2001-05-24
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
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
51407-637-01Primidone100 in 1 BOTTLETABLET1002
51407-637-05Primidone500 in 1 BOTTLETABLET5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-637-01EA - Each51407-637b61c12fb-15e3-43b5-b231-cb9b6fbe4a7f12022-09-12
51407-637-05EA - Each51407-637d521ba4e-d64d-42bd-8ad1-116e4f841b8f12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-637PRIMIDONE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC]2Current NDC, Legacy NDC, 2 package rows20241228_e4e493bd-94d7-7e5a-e053-2995a90a2706.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
96304primidone 250 MG Oral TabletPSNe4e493bd-94d7-7e5a-e053-2995a90a27062
198150primidone 50 MG Oral TabletPSNad8b50e2-e797-4326-a57e-d254da85b6b92
198150primidone 50 MG Oral TabletPSNe4e493bd-94d7-7e5a-e053-2995a90a27062
96304primidone 250 MG Oral TabletSCDe4e493bd-94d7-7e5a-e053-2995a90a27062
198150primidone 50 MG Oral TabletSCDad8b50e2-e797-4326-a57e-d254da85b6b92
198150primidone 50 MG Oral TabletSCDe4e493bd-94d7-7e5a-e053-2995a90a27062

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51407-637-0151407063701100 TABLET in 1 BOTTLE (51407-637-01) 100 tablet2022-02-030000-00-00NoNoCurrent
51407-637-0551407063705500 TABLET in 1 BOTTLE (51407-637-05) 500 tablet2022-02-030000-00-00NoNoCurrent