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| Product NDC Code | 70771-1315 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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, EXTENDED RELEASE | ||||||||||||
| RxCUI drug identifier | 1436239, 1437278, 1437283, 1437288 |
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| Application Number | ANDA207382 | ||||||||||||
| 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 CELLULOSE, MICROCRYSTALLINE ETHYLCELLULOSE, UNSPECIFIED FERROSOFERRIC OXIDE GELATIN HYDROGENATED CASTOR OIL HYPROMELLOSE, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED POTASSIUM HYDROXIDE POVIDONE PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE TRIETHYL CITRATE WATER WHITE OPAQUE WHITE OPAQUE 863 Topiramate Topiramate TOPIRAMATE TOPIRAMATE ETHYLCELLULOSE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED HYDROGENATED CASTOR OIL CELLULOSE, MICROCRYSTALLINE POVIDONE POLYETHYLENE GLYCOL, UNSPECIFIED TALC TRIETHYL CITRATE GELATIN SODIUM LAURYL SULFATE TITANIUM DIOXIDE FERROSOFERRIC OXIDE POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC WATER WHITE OPAQUE WHITE OPAQUE 864 Topiramate Topiramate TOPIRAMATE TOPIRAMATE ALCOHOL AMMONIA BUTYL ALCOHOL CELLULOSE, MICROCRYSTALLINE ETHYLCELLULOSE, UNSPECIFIED FERROSOFERRIC OXIDE GELATIN HYDROGENATED CASTOR OIL HYPROMELLOSE, UNSPECIFIED ISOPROPYL ALCOHOL POLYETHYLENE GLYCOL, UNSPECIFIED POTASSIUM HYDROXIDE POVIDONE PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE TRIETHYL CITRATE WATER WHITE OPAQUE WHITE OPAQUE 769 Topiramate Topiramate TOPIRAMATE TOPIRAMATE CELLULOSE, MICROCRYSTALLINE ETHYLCELLULOSE, UNSPECIFIED FERROSOFERRIC OXIDE GELATIN HYDROXYPROPYL CELLULOSE (90000 WAMW) HYPROMELLOSE, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE TRIETHYL CITRATE WATER WHITE OPAQUE WHITE OPAQUE 358
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 70771-1315-3 Topiramate extended-release capsules, 25 mg 30 capsules Rx only NDC 70771-1316-3 Topiramate extended-release capsules, 50 mg 30 capsules Rx only NDC 70771-1317-3 Topiramate extended-release capsules, 100 mg 30 capsules Rx only NDC 70771-1858-3 Topiramate extended-release capsules, 200 mg 30 capsules Rx only 25 mg 50 mg 100 mg 200 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