NDC 68382-769

Topiramate

Topiramate

Topiramate is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals Usa Inc.. The primary component is Topiramate.

Product ID68382-769_1e1ac74b-fc16-419a-bea8-3267ebc41b1b
NDC68382-769
Product TypeHuman Prescription Drug
Proprietary NameTopiramate
Generic NameTopiramate
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2018-04-05
Marketing CategoryANDA / ANDA
Application NumberANDA207382
Labeler NameZydus Pharmaceuticals USA Inc.
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 Through2023-12-31

Packaging

NDC 68382-769-01

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-769-01)
Marketing Start Date2018-04-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-769-30 [68382076930]

Topiramate CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207382
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-05

NDC 68382-769-77 [68382076977]

Topiramate CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207382
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-05

NDC 68382-769-01 [68382076901]

Topiramate CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207382
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-05

NDC 68382-769-16 [68382076916]

Topiramate CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207382
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-05

NDC 68382-769-06 [68382076906]

Topiramate CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207382
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-05

NDC 68382-769-05 [68382076905]

Topiramate CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207382
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-05

Drug Details

Active Ingredients

IngredientStrength
TOPIRAMATE100 mg/1

OpenFDA Data

SPL SET ID:f72774dd-c7eb-41f9-9837-02baf77cc523
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1437283
  • 1436239
  • 1437278

    • Pharmacological Class

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