NDC 0527-1301

Primidone

Primidone

Primidone is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Lannett Company, Inc.. The primary component is Primidone.

Product ID0527-1301_5825879a-e77d-4416-b031-ad6c9515b802
NDC0527-1301
Product TypeHuman Prescription Drug
Proprietary NamePrimidone
Generic NamePrimidone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2001-05-24
Marketing CategoryANDA / ANDA
Application NumberANDA084903
Labeler NameLannett Company, Inc.
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 Through2023-12-31

Packaging

NDC 0527-1301-01

100 TABLET in 1 BOTTLE (0527-1301-01)
Marketing Start Date2001-05-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0527-1301-01 [00527130101]

Primidone TABLET
Marketing CategoryANDA
Application NumberANDA084903
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2001-05-24

NDC 0527-1301-05 [00527130105]

Primidone TABLET
Marketing CategoryANDA
Application NumberANDA084903
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2001-05-24

NDC 0527-1301-10 [00527130110]

Primidone TABLET
Marketing CategoryANDA
Application NumberANDA084903
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2001-05-24

Drug Details

Active Ingredients

IngredientStrength
PRIMIDONE50 mg/1

OpenFDA Data

SPL SET ID:a1a817f7-c190-4825-94eb-442f477187e3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198150
  • 96304
    • UPC Code
  • 0305271231017
  • 0305271301017

    • 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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