NDC 0603-5371

Primidone

Primidone

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

Product ID0603-5371_1c33caad-ce65-4bde-a5cd-cada812bfbc5
NDC0603-5371
Product TypeHuman Prescription Drug
Proprietary NamePrimidone
Generic NamePrimidone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2005-02-24
Marketing End Date2021-10-31
Marketing CategoryANDA / ANDA
Application NumberANDA040586
Labeler NamePar Pharmaceutical
Substance NamePRIMIDONE
Active Ingredient Strength50 mg/1
Pharm ClassesAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN

Packaging

NDC 0603-5371-21

100 TABLET in 1 BOTTLE, PLASTIC (0603-5371-21)
Marketing Start Date2005-02-24
Marketing End Date2021-09-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0603-5371-10 [00603537110]

Primidone TABLET
Marketing CategoryANDA
Application NumberANDA040586
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-02-24
Marketing End Date2017-06-01

NDC 0603-5371-28 [00603537128]

Primidone TABLET
Marketing CategoryANDA
Application NumberANDA040586
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-02-24
Marketing End Date2021-10-31

NDC 0603-5371-21 [00603537121]

Primidone TABLET
Marketing CategoryANDA
Application NumberANDA040586
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-02-24
Marketing End Date2021-09-30

NDC 0603-5371-32 [00603537132]

Primidone TABLET
Marketing CategoryANDA
Application NumberANDA040586
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-02-24
Marketing End Date2017-06-01

Drug Details

Active Ingredients

IngredientStrength
PRIMIDONE50 mg/1

OpenFDA Data

SPL SET ID:cce71bdb-1018-4f94-90d4-cf3cc804fbb3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198150
  • 96304
    • UPC Code
  • 0306035371215
  • 0306035372212

    • Pharmacological Class

    • 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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