NDC 63187-773

Topiramate

Topiramate

Topiramate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Proficient Rx Lp. The primary component is Topiramate.

Product ID63187-773_2917ba32-3355-4d64-966a-8518e6fafdbe
NDC63187-773
Product TypeHuman Prescription Drug
Proprietary NameTopiramate
Generic NameTopiramate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2014-06-12
Marketing CategoryANDA / ANDA
Application NumberANDA076343
Labeler NameProficient Rx LP
Substance NameTOPIRAMATE
Active Ingredient Strength25 meq/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 Through2018-12-31

Packaging

NDC 63187-773-30

30 TABLET in 1 BOTTLE (63187-773-30)
Marketing Start Date2016-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63187-773-60 [63187077360]

Topiramate TABLET
Marketing CategoryANDA
Application NumberANDA076343
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-11-01
Inactivation Date2020-01-31
Reactivation Date2020-02-25

NDC 63187-773-30 [63187077330]

Topiramate TABLET
Marketing CategoryANDA
Application NumberANDA076343
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-11-01
Inactivation Date2020-01-31
Reactivation Date2020-02-25

NDC 63187-773-90 [63187077390]

Topiramate TABLET
Marketing CategoryANDA
Application NumberANDA076343
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-11-01
Inactivation Date2020-01-31
Reactivation Date2020-02-25

Drug Details

Active Ingredients

IngredientStrength
TOPIRAMATE25 meq/1

OpenFDA Data

SPL SET ID:2917ba32-3355-4d64-966a-8518e6fafdbe
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

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