NDC 53217-315

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 ID53217-315_c2d24d14-c656-4906-a1e4-9d7fee98b3c5
NDC53217-315
Product TypeHuman Prescription Drug
Proprietary NameTopiramate
Generic NameTopiramate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2014-06-12
Marketing CategoryANDA / ANDA
Application NumberANDA076343
Labeler NameAidarex Pharmaceuticals LLC
Substance NameTOPIRAMATE
Active Ingredient Strength50 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 53217-315-14

14 TABLET in 1 BOTTLE (53217-315-14)
Marketing Start Date2014-06-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53217-315-28 [53217031528]

Topiramate TABLET
Marketing CategoryANDA
Application NumberANDA076343
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-06-12
Inactivation Date2020-01-31

NDC 53217-315-90 [53217031590]

Topiramate TABLET
Marketing CategoryANDA
Application NumberANDA076343
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-06-12
Inactivation Date2020-01-31

NDC 53217-315-60 [53217031560]

Topiramate TABLET
Marketing CategoryANDA
Application NumberANDA076343
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-06-12
Inactivation Date2020-01-31

NDC 53217-315-07 [53217031507]

Topiramate TABLET
Marketing CategoryANDA
Application NumberANDA076343
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-06-12
Inactivation Date2020-01-31

NDC 53217-315-02 [53217031502]

Topiramate TABLET
Marketing CategoryANDA
Application NumberANDA076343
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-06-12
Inactivation Date2020-01-31

NDC 53217-315-14 [53217031514]

Topiramate TABLET
Marketing CategoryANDA
Application NumberANDA076343
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-06-12
Inactivation Date2020-01-31

NDC 53217-315-30 [53217031530]

Topiramate TABLET
Marketing CategoryANDA
Application NumberANDA076343
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-06-12
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
TOPIRAMATE50 mg/1

OpenFDA Data

SPL SET ID:299cf1b6-67ca-46ad-913d-5f474ae7b8a0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 151226

    • 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
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