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Topiramate - Medication Information

Product NDC Code 65841-647
Drug Name

Topiramate

Type Generic
Pharm Class Cytochrome P450 2C19 Inhibitors [MoA],
Cytochrome P450 3A4 Inducers [MoA],
Decreased Central Nervous System Disorganized Electrical Activity [PE]
Active Ingredients
Topiramate 25 mg/1
Route ORAL
Dosage Form TABLET, FILM COATED
RxCUI drug identifier 151226,
199888,
199889,
199890
Application Number ANDA078235
Labeler Name Zydus Lifesciences Limited
Packages
Package NDC Code Description
65841-647-01 100 tablet, film coated in 1 bottle (65841-647-01)
65841-647-05 500 tablet, film coated in 1 bottle (65841-647-05)
65841-647-14 60 tablet, film coated in 1 bottle (65841-647-14)
65841-647-16 90 tablet, film coated in 1 bottle (65841-647-16)
Check if available Online

Spl product data elements

Usually a list of ingredients in a drug product.
topiramate topiramate TOPIRAMATE TOPIRAMATE HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A POTATO TALC TITANIUM DIOXIDE SILICON DIOXIDE CELLULOSE, MICROCRYSTALLINE ANHYDROUS LACTOSE WHITE TO OFF-WHITE ROUND ZD;16 topiramate topiramate TOPIRAMATE TOPIRAMATE HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A POTATO TALC TITANIUM DIOXIDE SILICON DIOXIDE CELLULOSE, MICROCRYSTALLINE ANHYDROUS LACTOSE WHITE TO OFF-WHITE ROUND ZD;15 topiramate topiramate TOPIRAMATE TOPIRAMATE HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A POTATO TALC TITANIUM DIOXIDE SILICON DIOXIDE CELLULOSE, MICROCRYSTALLINE ANHYDROUS LACTOSE WHITE TO OFF-WHITE ROUND ZD;14 topiramate topiramate TOPIRAMATE TOPIRAMATE HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A POTATO TALC TITANIUM DIOXIDE SILICON DIOXIDE CELLULOSE, MICROCRYSTALLINE ANHYDROUS LACTOSE WHITE TO OFF-WHITE ROUND ZD;13

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-647-14 in bottle of 60 tablets Topiramate Tablets USP, 25 mg 60 tablets Rx only NDC 65841-648-14 in bottle of 60 tablets Topiramate Tablets USP, 50 mg 60 tablets Rx only NDC 65841-649-14 in bottle of 60 tablets Topiramate Tablets USP, 100 mg 60 tablets Rx only NDC 65841-650-14 in bottle of 60 tablets Topiramate Tablets USP, 200 mg 60 tablets Rx only Topiramate Tablets Topiramate Tablets Topiramate Tablets Topiramate Tablets

Spl medguide

Information about the patient medication guide that accompanies the drug product. Certain drugs must be dispensed with an accompanying medication guide. This field may contain information about when to consult the medication guide and the contents of the medication guide.
SPL MEDGUIDE

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API