NDC 71335-1147

topiramate

Topiramate

topiramate is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Topiramate.

Product ID71335-1147_2d4aff94-abcc-4564-8467-b68d889174de
NDC71335-1147
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 NameBryant Ranch Prepack
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 FlagN
Listing Certified Through2020-12-31

Packaging

NDC 71335-1147-1

30 TABLET, FILM COATED in 1 BOTTLE (71335-1147-1)
Marketing Start Date2019-03-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-1147-6 [71335114706]

topiramate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078235
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-15

NDC 71335-1147-8 [71335114708]

topiramate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078235
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-15

NDC 71335-1147-1 [71335114701]

topiramate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078235
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-03-15

NDC 71335-1147-7 [71335114707]

topiramate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078235
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-15

NDC 71335-1147-4 [71335114704]

topiramate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078235
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-15

NDC 71335-1147-2 [71335114702]

topiramate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078235
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-03-15

NDC 71335-1147-3 [71335114703]

topiramate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078235
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-03-15

NDC 71335-1147-5 [71335114705]

topiramate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078235
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-03-15

NDC 71335-1147-9 [71335114709]

topiramate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078235
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-15

Drug Details

Active Ingredients

IngredientStrength
TOPIRAMATE50 mg/1

OpenFDA Data

SPL SET ID:8abe45eb-cc75-4625-ae3d-5b2a038c4907
Manufacturer
UNII

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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