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Topiramate - Medication Information

Product NDC Code 65841-652
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 CAPSULE, COATED PELLETS
RxCUI drug identifier 205315,
205316
Application Number ANDA078877
Labeler Name Zydus Lifesciences Limited
Packages
Package NDC Code Description
65841-652-01 100 capsule, coated pellets in 1 bottle (65841-652-01)
65841-652-05 500 capsule, coated pellets in 1 bottle (65841-652-05)
65841-652-10 1000 capsule, coated pellets in 1 bottle (65841-652-10)
65841-652-14 60 capsule, coated pellets in 1 bottle (65841-652-14)
65841-652-16 90 capsule, coated pellets in 1 bottle (65841-652-16)
65841-652-17 28 capsule, coated pellets in 1 bottle (65841-652-17)
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Spl product data elements

Usually a list of ingredients in a drug product.
topiramate topiramate TOPIRAMATE TOPIRAMATE HYPROMELLOSES CELLULOSE ACETATE GELATIN POVIDONE SODIUM LAURYL SULFATE SUCROSE TALC TITANIUM DIOXIDE WHITE CAPSULE ZA63;15mg topiramate topiramate TOPIRAMATE TOPIRAMATE HYPROMELLOSES CELLULOSE ACETATE GELATIN POVIDONE SODIUM LAURYL SULFATE SUCROSE TALC TITANIUM DIOXIDE WHITE CAPSULE ZA64;25mg

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 65841-651-14 in bottle of 60 capsules Topiramate Capsules USP, 15 mg 60 capsules Rx only NDC 65841-652-14 in bottle of 60 capsules Topiramate Capsules USP, 25 mg 60 capsules Rx only Topiramate Capsules (Sprinkle), 15 mg Topiramate Capsules (Sprinkle), 25 mg

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