NDC 63629-3995

Topiramate

Topiramate

Topiramate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Topiramate.

Product ID63629-3995_6039fd1b-5061-4071-aba3-2da49374f26c
NDC63629-3995
Product TypeHuman Prescription Drug
Proprietary NameTopiramate
Generic NameTopiramate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-03-27
Marketing CategoryANDA / ANDA
Application NumberANDA079162
Labeler NameBryant Ranch Prepack
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 Through2017-12-31

Packaging

NDC 63629-3995-1

30 TABLET in 1 BOTTLE (63629-3995-1)
Marketing Start Date2009-03-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-3995-5 [63629399505]

Topiramate TABLET
Marketing CategoryANDA
Application NumberANDA079162
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-10-09
Inactivation Date2019-11-27

NDC 63629-3995-4 [63629399504]

Topiramate TABLET
Marketing CategoryANDA
Application NumberANDA079162
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-10-09
Inactivation Date2019-11-27

NDC 63629-3995-3 [63629399503]

Topiramate TABLET
Marketing CategoryANDA
Application NumberANDA079162
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-03-27
Inactivation Date2019-11-27

NDC 63629-3995-7 [63629399507]

Topiramate TABLET
Marketing CategoryANDA
Application NumberANDA079162
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-07-24
Inactivation Date2019-11-27

NDC 63629-3995-1 [63629399501]

Topiramate TABLET
Marketing CategoryANDA
Application NumberANDA079162
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-03-27
Inactivation Date2019-11-27

NDC 63629-3995-2 [63629399502]

Topiramate TABLET
Marketing CategoryANDA
Application NumberANDA079162
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-03-27
Inactivation Date2019-11-27

NDC 63629-3995-6 [63629399506]

Topiramate TABLET
Marketing CategoryANDA
Application NumberANDA079162
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-07-24
Inactivation Date2019-11-27

NDC 63629-3995-8 [63629399508]

Topiramate TABLET
Marketing CategoryANDA
Application NumberANDA079162
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-07-24
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
TOPIRAMATE50 mg/1

OpenFDA Data

SPL SET ID:6c94e2e1-6290-4a81-893c-9e99cb651df7
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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