NDC 43063-538

TOPIRAMATE

Topiramate

TOPIRAMATE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, Inc.. The primary component is Topiramate.

Product ID43063-538_7d4df0eb-9212-1435-e053-2a91aa0a05f5
NDC43063-538
Product TypeHuman Prescription Drug
Proprietary NameTOPIRAMATE
Generic NameTopiramate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-03-27
Marketing CategoryANDA / ANDA
Application NumberANDA079153
Labeler NamePD-Rx Pharmaceuticals, Inc.
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 FlagN
Listing Certified Through2019-12-31

Packaging

NDC 43063-538-60

60 TABLET in 1 BOTTLE, PLASTIC (43063-538-60)
Marketing Start Date2015-04-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43063-538-60 [43063053860]

TOPIRAMATE TABLET
Marketing CategoryANDA
Application NumberANDA079153
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-04-27
Marketing End Date2020-01-22

NDC 43063-538-30 [43063053830]

TOPIRAMATE TABLET
Marketing CategoryANDA
Application NumberANDA079153
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-10-06
Marketing End Date2020-01-22

Drug Details

Active Ingredients

IngredientStrength
TOPIRAMATE50 mg/1

OpenFDA Data

SPL SET ID:0312ba87-6188-4695-8b2b-05c3da2f7a96
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 151226
    • UPC Code
  • 0343063538302

    • 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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