NDC 55111-476

Primidone

Primidone

Primidone is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Dr. Reddy's Laboratories Limited. The primary component is Primidone.

Product ID55111-476_6f5c36d3-3f99-803c-5be6-66b2e1058946
NDC55111-476
Product TypeHuman Prescription Drug
Proprietary NamePrimidone
Generic NamePrimidone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2008-10-03
Marketing CategoryANDA / ANDA
Application NumberANDA040862
Labeler NameDr. Reddy's Laboratories Limited
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 Through2020-12-31

Packaging

NDC 55111-476-01

100 TABLET in 1 BOTTLE (55111-476-01)
Marketing Start Date2008-10-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55111-476-78 [55111047678]

Primidone TABLET
Marketing CategoryANDA
Application NumberANDA040862
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-10-03

NDC 55111-476-60 [55111047660]

Primidone TABLET
Marketing CategoryANDA
Application NumberANDA040862
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-10-03

NDC 55111-476-05 [55111047605]

Primidone TABLET
Marketing CategoryANDA
Application NumberANDA040862
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-10-03

NDC 55111-476-30 [55111047630]

Primidone TABLET
Marketing CategoryANDA
Application NumberANDA040862
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-10-03

NDC 55111-476-01 [55111047601]

Primidone TABLET
Marketing CategoryANDA
Application NumberANDA040862
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-10-03

NDC 55111-476-79 [55111047679]

Primidone TABLET
Marketing CategoryANDA
Application NumberANDA040862
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-03-19

Drug Details

Active Ingredients

IngredientStrength
PRIMIDONE250 mg/1

OpenFDA Data

SPL SET ID:a4f917f4-2aa2-c3ed-071e-232fa0f125e8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198150
  • 96304

    • 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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.