NDC 53217-274

Topiramate

Topiramate

Topiramate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Aidarex Pharmaceuticals Llc. The primary component is Topiramate.

Product ID53217-274_48b93744-8bad-46fc-aff5-39197b5ff2bc
NDC53217-274
Product TypeHuman Prescription Drug
Proprietary NameTopiramate
Generic NameTopiramate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-07-22
Marketing CategoryANDA / ANDA
Application NumberANDA079162
Labeler NameAidarex Pharmaceuticals LLC
Substance NameTOPIRAMATE
Active Ingredient Strength100 mg/1
Pharm ClassesDecreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 53217-274-02

120 TABLET in 1 BOTTLE (53217-274-02)
Marketing Start Date2016-07-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53217-274-60 [53217027460]

Topiramate TABLET
Marketing CategoryANDA
Application NumberANDA079162
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-07-22
Inactivation Date2020-01-31

NDC 53217-274-02 [53217027402]

Topiramate TABLET
Marketing CategoryANDA
Application NumberANDA079162
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-07-22
Inactivation Date2020-01-31

NDC 53217-274-30 [53217027430]

Topiramate TABLET
Marketing CategoryANDA
Application NumberANDA079162
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-07-22
Inactivation Date2020-01-31

NDC 53217-274-90 [53217027490]

Topiramate TABLET
Marketing CategoryANDA
Application NumberANDA079162
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-07-22
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
TOPIRAMATE100 mg/1

OpenFDA Data

SPL SET ID:37da3ab9-df44-444e-b506-41204601cf43
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 199889

    • Pharmacological Class

    • Decreased Central Nervous System Disorganized Electrical Activity [PE]
    • Cytochrome P450 3A4 Inducers [MoA]
    • Cytochrome P450 2C19 Inhibitors [MoA]

    NDC Crossover Matching brand name "Topiramate" or generic name "Topiramate"

    NDCBrand NameGeneric Name
    0093-7335TopiramateTopiramate
    0093-7336TopiramateTopiramate
    0615-7562TopiramateTopiramate
    0615-7563TopiramateTopiramate
    0615-7564TopiramateTopiramate
    0615-7565TopiramateTopiramate
    0615-8138TopiramateTopiramate
    0615-8139TopiramateTopiramate
    68071-3012TopiramateTopiramate
    68071-3088TopiramateTopiramate
    68071-3196TopiramateTopiramate
    68071-1960TopiramateTopiramate
    68071-1971TopiramateTopiramate
    68071-1900TopiramateTopiramate
    68071-4793topiramatetopiramate
    68071-4760topiramatetopiramate
    68084-344TopiramateTopiramate
    68084-342TopiramateTopiramate
    68071-4756topiramatetopiramate
    68084-345TopiramateTopiramate
    68258-7159TOPIRAMATETOPIRAMATE
    68382-138topiramatetopiramate
    68382-004topiramatetopiramate
    68258-3000TOPIRAMATETOPIRAMATE
    68258-3002TOPIRAMATETOPIRAMATE
    68258-3001TOPIRAMATETOPIRAMATE
    68382-139topiramatetopiramate
    68258-7056TOPIRAMATETOPIRAMATE
    68382-140topiramatetopiramate
    68382-005topiramatetopiramate
    68258-7156TOPIRAMATETOPIRAMATE
    68382-141topiramatetopiramate
    68382-769TopiramateTopiramate
    68382-864TopiramateTopiramate
    68387-559TopiramateTopiramate
    68387-558TopiramateTopiramate
    68387-560TopiramateTopiramate
    68382-863TopiramateTopiramate
    68462-109TopiramateTopiramate
    68462-110TopiramateTopiramate
    68462-108TopiramateTopiramate
    68462-153TopiramateTopiramate
    68788-6435TopiramateTopiramate
    68788-7016TopiramateTopiramate
    68788-6377TopiramateTopiramate
    68788-6770TopiramateTopiramate
    68788-7351topiramatetopiramate
    68788-8965TopiramateTopiramate
    68788-6366TopiramateTopiramate
    68788-6916TopiramateTopiramate
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.