NDC 0615-7563

Topiramate

Topiramate

Topiramate is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Ncs Healthcare Of Ky, Inc Dba Vangard Labs. The primary component is Topiramate.

Product ID0615-7563_d8d1e518-2b20-4a4b-bd1d-f13c9f762d7a
NDC0615-7563
Product TypeHuman Prescription Drug
Proprietary NameTopiramate
Generic NameTopiramate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2009-03-27
Marketing CategoryANDA / ANDA
Application NumberANDA078235
Labeler NameNCS HealthCare of KY, Inc dba Vangard Labs
Substance NameTOPIRAMATE
Active Ingredient Strength50 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 0615-7563-05

15 TABLET, FILM COATED in 1 BLISTER PACK (0615-7563-05)
Marketing Start Date2009-03-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0615-7563-39 [00615756339]

Topiramate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078235
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-03-27
Inactivation Date2019-11-13

NDC 0615-7563-05 [00615756305]

Topiramate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078235
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-03-27
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
TOPIRAMATE50 mg/1

OpenFDA Data

SPL SET ID:7f9eb38f-0dfa-4798-b3c1-32381d33affa
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 151226
  • 199889
  • 199888
  • 199890

    • 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
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