NDC 13668-033

TOPIRAMATE

Topiramate

TOPIRAMATE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Torrent Pharmaceuticals Limited. The primary component is Topiramate.

Product ID13668-033_16ea5453-3213-4fef-9918-92f5c7179798
NDC13668-033
Product TypeHuman Prescription Drug
Proprietary NameTOPIRAMATE
Generic NameTopiramate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-03-27
Marketing CategoryANDA / ANDA
Application NumberANDA079153
Labeler NameTorrent Pharmaceuticals Limited
Substance NameTOPIRAMATE
Active Ingredient Strength100 mg/1
Pharm ClassesCytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN
Listing Certified Through2024-12-31

Packaging

NDC 13668-033-01

100 TABLET in 1 BOTTLE (13668-033-01)
Marketing Start Date2009-03-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 13668-033-60 [13668003360]

TOPIRAMATE TABLET
Marketing CategoryANDA
Application NumberANDA079153
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-03-27
Marketing End Date2017-04-30

NDC 13668-033-05 [13668003305]

TOPIRAMATE TABLET
Marketing CategoryANDA
Application NumberANDA079153
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-03-27
Marketing End Date2017-04-30

NDC 13668-033-31 [13668003331]

TOPIRAMATE TABLET
Marketing CategoryANDA
Application NumberANDA079153
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-03-27
Marketing End Date2017-04-30

NDC 13668-033-64 [13668003364]

TOPIRAMATE TABLET
Marketing CategoryANDA
Application NumberANDA079153
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-03-27
Marketing End Date2017-04-30

NDC 13668-033-01 [13668003301]

TOPIRAMATE TABLET
Marketing CategoryANDA
Application NumberANDA079153
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-03-27
Marketing End Date2017-04-30

Drug Details

Active Ingredients

IngredientStrength
TOPIRAMATE100 mg/1

OpenFDA Data

SPL SET ID:a4ff77b8-04bc-4edb-a085-8d6d8687f8d1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 151226
  • 199889
  • 199888
  • 199890
    • UPC Code
  • 0313668034059
  • 0313668031058
  • 0313668033052

    • Pharmacological Class

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

    Medicade Reported Pricing

    13668033930 LAMOTRIGINE ER 25 MG TABLET

    Pricing Unit: EA | Drug Type:

    13668033301 TRAZODONE 300 MG TABLET

    Pricing Unit: EA | Drug Type:

    13668033205 TRAZODONE 150 MG TABLET

    Pricing Unit: EA | Drug Type:

    13668033201 TRAZODONE 150 MG TABLET

    Pricing Unit: EA | Drug Type:

    13668033105 TRAZODONE 100 MG TABLET

    Pricing Unit: EA | Drug Type:

    13668033101 TRAZODONE 100 MG TABLET

    Pricing Unit: EA | Drug Type:

    13668033005 TRAZODONE 50 MG TABLET

    Pricing Unit: EA | Drug Type:

    13668033001 TRAZODONE 50 MG TABLET

    Pricing Unit: EA | Drug Type:

    13668003360 TOPIRAMATE 100 MG TABLET

    Pricing Unit: EA | Drug Type:

    13668003305 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.