NDC 68382-140

topiramate

Topiramate

topiramate is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Topiramate.

Product ID68382-140_2597a79d-bdec-463e-b98f-75e61e24e060
NDC68382-140
Product TypeHuman Prescription Drug
Proprietary Nametopiramate
Generic NameTopiramate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2009-03-27
Marketing CategoryANDA / ANDA
Application NumberANDA078235
Labeler NameZydus Pharmaceuticals (USA) Inc.
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 FlagN
Listing Certified Through2022-12-31

Packaging

NDC 68382-140-01

100 TABLET, FILM COATED in 1 BOTTLE (68382-140-01)
Marketing Start Date2009-03-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-140-14 [68382014014]

topiramate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078235
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-03-27

NDC 68382-140-05 [68382014005]

topiramate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078235
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-03-27

NDC 68382-140-16 [68382014016]

topiramate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078235
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-03-27

NDC 68382-140-01 [68382014001]

topiramate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078235
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-03-27

Drug Details

Active Ingredients

IngredientStrength
TOPIRAMATE100 mg/1

OpenFDA Data

SPL SET ID:67dcdd6e-48bc-418e-a887-805929d83ce0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 151226
  • 199889
  • 199888
  • 199890
  • Pharmacological Class

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

    Medicade Reported Pricing

    68382014014 TOPIRAMATE 100 MG TABLET

    Pricing Unit: EA | Drug Type:

    68382014005 TOPIRAMATE 100 MG TABLET

    Pricing Unit: EA | Drug Type:

    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.