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Topiramate
Topiramate - 0378-6103-05 - (topiramate)
Drug Information of Topiramate
| Product NDC: | 0378-6103 |
| Proprietary Name: | Topiramate |
| Non Proprietary Name: | topiramate |
| Active Ingredient(s): | 100 mg/1 & nbsp; topiramate |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of Topiramate
| Product NDC: | 0378-6103 |
| Labeler Name: | Mylan Pharmaceuticals Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA076314 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20121212 |
Package Information of Topiramate
| Package NDC: | 0378-6103-05 |
| Package Description: | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6103-05) |
NDC Information of Topiramate
| NDC Code | 0378-6103-05 |
| Proprietary Name | Topiramate |
| Package Description | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6103-05) |
| Product NDC | 0378-6103 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | topiramate |
| Dosage Form Name | TABLET, FILM COATED |
| Route Name | ORAL |
| Start Marketing Date | 20121212 |
| Marketing Category Name | ANDA |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Substance Name | TOPIRAMATE |
| Strength Number | 100 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] |
