NDC 65162-545

Primidone

Primidone

Primidone is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Llc. The primary component is Primidone.

Product ID65162-545_1ae889da-b34c-4b0b-b16e-ccfd83de9761
NDC65162-545
Product TypeHuman Prescription Drug
Proprietary NamePrimidone
Generic NamePrimidone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-12-24
Marketing CategoryANDA / ANDA
Application NumberANDA040866
Labeler NameAmneal Pharmaceuticals LLC
Substance NamePRIMIDONE
Active Ingredient Strength250 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 65162-545-10

100 TABLET in 1 BOTTLE (65162-545-10)
Marketing Start Date2009-12-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65162-545-11 [65162054511]

Primidone TABLET
Marketing CategoryANDA
Application NumberANDA040866
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-24

NDC 65162-545-10 [65162054510]

Primidone TABLET
Marketing CategoryANDA
Application NumberANDA040866
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-12-24

NDC 65162-545-50 [65162054550]

Primidone TABLET
Marketing CategoryANDA
Application NumberANDA040866
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-24

Drug Details

Active Ingredients

IngredientStrength
PRIMIDONE250 mg/1

OpenFDA Data

SPL SET ID:02ba0182-0870-4c0d-a814-a1dc427d47b8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198150
  • 96304
  • UPC Code
  • 0365162545104
  • Pharmacological Class

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

    Medicade Reported Pricing

    65162054510 PRIMIDONE 250 MG TABLET

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    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
    68084-203PrimidonePrimidone
    68084-202PrimidonePrimidone
    68682-690PrimidonePrimidone
    68682-691PrimidonePrimidone
    71610-191PrimidonePrimidone
    71610-005PrimidonePrimidone
    71610-079PrimidonePrimidone
    53746-545PrimidonePrimidone
    55111-477PrimidonePrimidone
    55111-476PrimidonePrimidone
    63629-7811PrimidonePrimidone
    65162-544PrimidonePrimidone
    65162-545PrimidonePrimidone
    71335-1158PrimidonePrimidone

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