NDC 61919-185

TOPIRAMATE

Topiramate Tablet

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

Product ID61919-185_f8495948-ec6f-49ad-8385-f3a79b64403e
NDC61919-185
Product TypeHuman Prescription Drug
Proprietary NameTOPIRAMATE
Generic NameTopiramate Tablet
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2015-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA079153
Labeler NameDIRECT RX
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 FlagE
Listing Certified Through2017-12-31

Packaging

NDC 61919-185-60

60 TABLET in 1 BOTTLE (61919-185-60)
Marketing Start Date2015-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-185-60 [61919018560]

TOPIRAMATE TABLET
Marketing CategoryANDA
Application NumberANDA079153
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-01
Inactivation Date2020-01-31

NDC 61919-185-30 [61919018530]

TOPIRAMATE TABLET
Marketing CategoryANDA
Application NumberANDA079153
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
TOPIRAMATE100 mg/1

OpenFDA Data

SPL SET ID:0f686676-8d66-4f29-966c-0a31e2eee90c
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 Tablet"

    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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