NDC 0832-1074

Topiramate

Topiramate

Topiramate is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Upsher-smith Laboratories, Llc. The primary component is Topiramate.

Product ID0832-1074_78544737-0790-474c-9e4a-0bd4f8facb45
NDC0832-1074
Product TypeHuman Prescription Drug
Proprietary NameTopiramate
Generic NameTopiramate
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2014-07-07
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA205122
Labeler NameUpsher-Smith Laboratories, LLC
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 0832-1074-15

500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0832-1074-15)
Marketing Start Date2014-07-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0832-1074-30 [00832107430]

Topiramate CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA authorized generic
Application NumberNDA205122
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-07-07

NDC 0832-1074-15 [00832107415]

Topiramate CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA authorized generic
Application NumberNDA205122
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-07-07

NDC 0832-1074-90 [00832107490]

Topiramate CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA authorized generic
Application NumberNDA205122
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-07-07

Drug Details

Active Ingredients

IngredientStrength
TOPIRAMATE100 mg/1

OpenFDA Data

SPL SET ID:691d276c-9cc1-4d39-828f-0f44d7ef6328
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1812421
  • 1812419
  • 1812427
  • 1812425
  • 1494769
    • UPC Code
  • 0308321073308
  • 0308321072301
  • 0308321075302
  • 0308321074305

    • 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.