NDC 71610-079

Primidone

Primidone

Primidone is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Primidone.

Product ID71610-079_2d04438d-30db-4621-aa15-03b25aa283ff
NDC71610-079
Product TypeHuman Prescription Drug
Proprietary NamePrimidone
Generic NamePrimidone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-03-28
Marketing CategoryANDA / ANDA
Application NumberANDA040586
Labeler NameAphena Pharma Solutions - Tennessee, LLC
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 Through2020-12-31

Packaging

NDC 71610-079-60

90 TABLET in 1 BOTTLE, PLASTIC (71610-079-60)
Marketing Start Date2018-05-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71610-079-80 [71610007980]

Primidone TABLET
Marketing CategoryANDA
Application NumberANDA040586
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-05-31

NDC 71610-079-94 [71610007994]

Primidone TABLET
Marketing CategoryANDA
Application NumberANDA040586
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-05-31

NDC 71610-079-60 [71610007960]

Primidone TABLET
Marketing CategoryANDA
Application NumberANDA040586
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-05-31

Drug Details

Active Ingredients

IngredientStrength
PRIMIDONE50 mg/1

OpenFDA Data

SPL SET ID:3e081b24-20f5-4ffd-b493-771fd4ac2c96
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198150
  • Pharmacological Class

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

    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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