NDC 54569-6137

topiramate

Topiramate

topiramate is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Topiramate.

Product ID54569-6137_7bb8333d-1eb8-49dc-816c-20caf9d2acfb
NDC54569-6137
Product TypeHuman Prescription Drug
Proprietary Nametopiramate
Generic NameTopiramate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2013-07-01
Marketing CategoryANDA / ANDA
Application NumberANDA090162
Labeler NameA-S Medication Solutions
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 FlagE
Listing Certified Through2017-12-31

Packaging

NDC 54569-6137-2

30 TABLET, FILM COATED in 1 BOTTLE (54569-6137-2)
Marketing Start Date2013-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54569-6137-2 [54569613702]

topiramate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090162
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-07-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
TOPIRAMATE25 mg/1

OpenFDA Data

SPL SET ID:10ad2819-17cf-4036-b3f7-c72bf1c00cf8
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.