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| Product NDC Code | 65841-846 | ||||
|---|---|---|---|---|---|
| Drug Name | Topiramate |
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| Type | Generic | ||||
| Pharm Class | Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | CAPSULE, COATED PELLETS | ||||
| RxCUI drug identifier | 205315, 205316, 252413 |
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| Application Number | ANDA078877 | ||||
| Labeler Name | Zydus Lifesciences Limited | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
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 WATER FERROSOFERRIC OXIDE POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC WHITE CAPSULE ZA63;15mg topiramate topiramate TOPIRAMATE TOPIRAMATE HYPROMELLOSES CELLULOSE ACETATE GELATIN POVIDONE SODIUM LAURYL SULFATE SUCROSE TALC TITANIUM DIOXIDE WATER FERROSOFERRIC OXIDE SHELLAC POTASSIUM HYDROXIDE PROPYLENE GLYCOL WHITE CAPSULE ZA64;25mg topiramate topiramate TOPIRAMATE TOPIRAMATE HYPROMELLOSES CELLULOSE ACETATE GELATIN POVIDONE SODIUM LAURYL SULFATE SUCROSE TALC TITANIUM DIOXIDE WATER PROPYLENE GLYCOL POTASSIUM HYDROXIDE SHELLAC FERROSOFERRIC OXIDE WHITE CAPSULE 50mg
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 NDC 65841-100-14 in bottle of 60 capsules Topiramate Capsules USP, 50 mg 60 capsules Rx only Topiramate Capsules (Sprinkle), 15 mg Topiramate Capsules (Sprinkle), 25 mg 50 mg label
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