NDC 70518-1196

Topiramate

Topiramate

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

Product ID70518-1196_6c482648-c5df-b7dc-e053-2991aa0a3d52
NDC70518-1196
Product TypeHuman Prescription Drug
Proprietary NameTopiramate
Generic NameTopiramate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-05-15
Marketing CategoryANDA / ANDA
Application NumberANDA076343
Labeler NameREMEDYREPACK 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 Through2019-12-31

Packaging

NDC 70518-1196-1

30 POUCH in 1 BOTTLE, UNIT-DOSE (70518-1196-1) > 1 TABLET in 1 POUCH (70518-1196-2)
Marketing Start Date2019-10-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1196-0 [70518119600]

Topiramate TABLET
Marketing CategoryANDA
Application NumberANDA076343
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-15

NDC 70518-1196-1 [70518119601]

Topiramate TABLET
Marketing CategoryANDA
Application NumberANDA076343
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-10-22

NDC 70518-1196-2 [70518119602]

Topiramate TABLET
Marketing CategoryANDA
Application NumberANDA076343
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-10-25

Drug Details

Active Ingredients

IngredientStrength
TOPIRAMATE100 mg/1

OpenFDA Data

SPL SET ID:44095c2b-2e90-45d2-ab45-d0961c41550d
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.