NDC 66490-690

Mysoline

Primidone

Mysoline is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Valeant Pharmaceuticals North America. The primary component is Primidone.

Product ID66490-690_16ea26a8-99f6-43bb-bff4-588e95d9d508
NDC66490-690
Product TypeHuman Prescription Drug
Proprietary NameMysoline
Generic NamePrimidone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-06-24
Marketing CategoryNDA / NDA
Application NumberNDA009170
Labeler NameValeant Pharmaceuticals North America
Substance NamePRIMIDONE
Active Ingredient Strength50 mg/1
Pharm ClassesAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 66490-690-10

100 TABLET in 1 BOTTLE (66490-690-10)
Marketing Start Date2009-06-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66490-690-50 [66490069050]

Mysoline TABLET
Marketing CategoryNDA
Application NumberNDA009170
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-06-24
Marketing End Date2010-06-07

NDC 66490-690-10 [66490069010]

Mysoline TABLET
Marketing CategoryNDA
Application NumberNDA009170
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-06-24

Drug Details

Active Ingredients

IngredientStrength
PRIMIDONE50 mg/1

OpenFDA Data

SPL SET ID:af593171-dabb-4ea3-b44c-89ed457b2c46
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198150
  • 201747
  • 207478
  • 96304

    • Pharmacological Class

    • Anti-epileptic Agent [EPC]
    • Decreased Central Nervous System Disorganized Electrical Activity [PE]

    Medicade Reported Pricing

    66490069010 MYSOLINE 50 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Mysoline" or generic name "Primidone"

    NDCBrand NameGeneric Name
    66490-691MysolineMysoline
    66490-690MysolineMysoline
    0143-1482PrimidonePrimidone
    0143-1484PrimidonePrimidone
    0527-1231PrimidonePrimidone
    0527-1301PrimidonePrimidone
    0591-5321PrimidonePrimidone
    0603-5371Primidoneprimidone
    0603-5372Primidoneprimidone
    0615-2521Primidoneprimidone
    0615-5591PrimidonePrimidone
    0615-7738PrimidonePrimidone
    0615-7936Primidoneprimidone
    0615-8206PrimidonePrimidone
    0904-5559PrimidonePrimidone
    10135-522PrimidonePrimidone
    10135-540PrimidonePrimidone
    42291-508Primidoneprimidone
    42291-509PrimidonePrimidone
    42291-511PrimidonePrimidone
    50090-1622PrimidonePrimidone
    50090-1636PrimidonePrimidone
    50090-4083PrimidonePrimidone
    50268-686PrimidonePrimidone
    50268-687PrimidonePrimidone
    51407-637PrimidonePrimidone
    51407-638PrimidonePrimidone
    53746-544PrimidonePrimidone

    Trademark Results [Mysoline]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MYSOLINE
    MYSOLINE
    71620216 0569143 Live/Registered
    IMPERIAL CHEMICAL (PHARMACEUTICALS) LIMITED
    1951-10-19
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