NDC 68788-7016

Topiramate

Topiramate

Topiramate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Preferred Pharmaceuticals Inc.. The primary component is Topiramate.

Product ID68788-7016_06edd241-4203-4227-95ad-c9c90f14b70c
NDC68788-7016
Product TypeHuman Prescription Drug
Proprietary NameTopiramate
Generic NameTopiramate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-10-03
Marketing CategoryANDA / ANDA
Application NumberANDA076343
Labeler NamePreferred Pharmaceuticals Inc.
Substance NameTOPIRAMATE
Active Ingredient Strength25 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 68788-7016-9

90 TABLET in 1 BOTTLE (68788-7016-9)
Marketing Start Date2017-10-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-7016-6 [68788701606]

Topiramate TABLET
Marketing CategoryANDA
Application NumberANDA076343
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-03

NDC 68788-7016-5 [68788701605]

Topiramate TABLET
Marketing CategoryANDA
Application NumberANDA076343
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-03

NDC 68788-7016-3 [68788701603]

Topiramate TABLET
Marketing CategoryANDA
Application NumberANDA076343
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-03

NDC 68788-7016-9 [68788701609]

Topiramate TABLET
Marketing CategoryANDA
Application NumberANDA076343
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-03

Drug Details

Active Ingredients

IngredientStrength
TOPIRAMATE25 meq/1

OpenFDA Data

SPL SET ID:ce07c1c5-5d85-4b73-a9c2-cd946f07c54f
Manufacturer
UNII

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.