NDC 68382-004

topiramate

Topiramate

topiramate is a Oral Capsule, Coated Pellets in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Topiramate.

Product ID68382-004_5cca6ad6-6a50-4986-85dd-00f66499697d
NDC68382-004
Product TypeHuman Prescription Drug
Proprietary Nametopiramate
Generic NameTopiramate
Dosage FormCapsule, Coated Pellets
Route of AdministrationORAL
Marketing Start Date2009-10-14
Marketing CategoryANDA / ANDA
Application NumberANDA078877
Labeler NameZydus Pharmaceuticals (USA) Inc.
Substance NameTOPIRAMATE
Active Ingredient Strength15 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 Through2021-12-31

Packaging

NDC 68382-004-01

100 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-004-01)
Marketing Start Date2009-10-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-004-14 [68382000414]

topiramate CAPSULE, COATED PELLETS
Marketing CategoryANDA
Application NumberANDA078877
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-10-14

NDC 68382-004-10 [68382000410]

topiramate CAPSULE, COATED PELLETS
Marketing CategoryANDA
Application NumberANDA078877
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-10-14

NDC 68382-004-01 [68382000401]

topiramate CAPSULE, COATED PELLETS
Marketing CategoryANDA
Application NumberANDA078877
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-10-14

NDC 68382-004-16 [68382000416]

topiramate CAPSULE, COATED PELLETS
Marketing CategoryANDA
Application NumberANDA078877
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-10-14

NDC 68382-004-05 [68382000405]

topiramate CAPSULE, COATED PELLETS
Marketing CategoryANDA
Application NumberANDA078877
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-10-14

Drug Details

Active Ingredients

IngredientStrength
TOPIRAMATE15 mg/1

OpenFDA Data

SPL SET ID:e4886adf-199d-4b19-a4ef-75f8f94cb54e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 205316
  • 205315

    • Pharmacological Class

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

    Medicade Reported Pricing

    68382004603 RIBAVIRIN 200 MG TABLET

    Pricing Unit: EA | Drug Type:

    68382004201 PROMETHAZINE 50 MG TABLET

    Pricing Unit: EA | Drug Type:

    68382004110 PROMETHAZINE 25 MG TABLET

    Pricing Unit: EA | Drug Type:

    68382004101 PROMETHAZINE 25 MG TABLET

    Pricing Unit: EA | Drug Type:

    68382004001 PROMETHAZINE 12.5 MG TABLET

    Pricing Unit: EA | Drug Type:

    68382000414 TOPIRAMATE 15 MG SPRINKLE CAP

    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
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