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| Product NDC Code | 70771-1657 | ||||||
|---|---|---|---|---|---|---|---|
| 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 | 1494769, 1812419, 1812421, 1812425, 1812427 |
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| Application Number | ANDA208949 | ||||||
| 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 ETHYLCELLULOSE (10 MPA.S) ETHYLCELLULOSE (45 MPA.S) FERRIC OXIDE RED FERROSOFERRIC OXIDE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED HYPROMELLOSE 2910 (15 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC TALC TITANIUM DIOXIDE TRIETHYL CITRATE WATER FLESH OPAQUE CAP WHITE OPAQUE BODY CAPSULE 1039 Topiramate Topiramate TOPIRAMATE TOPIRAMATE ETHYLCELLULOSE (10 MPA.S) ETHYLCELLULOSE (45 MPA.S) FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED HYPROMELLOSE 2910 (15 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC TALC TITANIUM DIOXIDE TRIETHYL CITRATE WATER IVORY OPAQUE CAP WHITE OPAQUE BODY CAPSULE 1040 Topiramate Topiramate TOPIRAMATE TOPIRAMATE ETHYLCELLULOSE (10 MPA.S) ETHYLCELLULOSE (45 MPA.S) FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED HYPROMELLOSE 2910 (15 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC TALC TITANIUM DIOXIDE TRIETHYL CITRATE WATER MEDIUM ORANGE OPAQUE CAP WHITE OPAQUE BODY CAPSULE 1041 Topiramate Topiramate TOPIRAMATE TOPIRAMATE ETHYLCELLULOSE (10 MPA.S) ETHYLCELLULOSE (45 MPA.S) FERROSOFERRIC OXIDE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED HYPROMELLOSE 2910 (15 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC TALC TITANIUM DIOXIDE TRIETHYL CITRATE WATER WHITE OPAQUE CAP WHITE OPAQUE BODY CAPSULE 1042 Topiramate Topiramate TOPIRAMATE TOPIRAMATE ETHYLCELLULOSE (10 MPA.S) ETHYLCELLULOSE (45 MPA.S) FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED HYPROMELLOSE 2910 (15 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC TALC TITANIUM DIOXIDE TRIETHYL CITRATE WATER LIGHT GREEN OPAQUE CAP WHITE OPAQUE BODY CAPSULE 1043
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 70771-1656-3 Topiramate extended-release Capsules 25 mg Rx only 30 Capsules NDC 70771-1657-3 Topiramate extended-release Capsules 50 mg Rx only 30 Capsules NDC 70771-1658-3 Topiramate extended-release Capsules 100 mg Rx only 30 Capsules NDC 70771-1659-3 Topiramate extended-release Capsules 150 mg Rx only 30 Capsules NDC 70771-1660-3 Topiramate extended-release Capsules 200 mg Rx only 30 Capsules 25 mg label 50 mg label 100 mg label 150 mg label 200 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