NDC 0615-5591

Primidone

Primidone

Primidone is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Ncs Healthcare Of Ky, Inc Dba Vangard Labs. The primary component is Primidone.

Product ID0615-5591_4bd1672f-54df-4a23-a7cd-dd63d302abdc
NDC0615-5591
Product TypeHuman Prescription Drug
Proprietary NamePrimidone
Generic NamePrimidone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2001-05-24
Marketing CategoryANDA / ANDA
Application NumberANDA084903
Labeler NameNCS HealthCare of KY, Inc dba Vangard Labs
Substance NamePRIMIDONE
Active Ingredient Strength50 mg/1
Pharm ClassesAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 0615-5591-39

30 TABLET in 1 BLISTER PACK (0615-5591-39)
Marketing Start Date2001-05-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0615-5591-31 [00615559131]

Primidone TABLET
Marketing CategoryANDA
Application NumberANDA084903
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2001-05-24
Marketing End Date2014-12-18

NDC 0615-5591-39 [00615559139]

Primidone TABLET
Marketing CategoryANDA
Application NumberANDA084903
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2001-05-24
Inactivation Date2020-01-31

NDC 0615-5591-30 [00615559130]

Primidone TABLET
Marketing CategoryANDA
Application NumberANDA084903
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-12-18
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PRIMIDONE50 mg/1

OpenFDA Data

SPL SET ID:418a70aa-8480-4748-a1a8-af39f4962bf0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198150
  • 96304

    • 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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