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NDC 68382-0864-77 Topiramate 50 mg/1 Details
Topiramate 50 mg/1
Topiramate is a ORAL CAPSULE, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Pharmaceuticals USA Inc.. The primary component is TOPIRAMATE.
MedlinePlus Drug Summary
Topiramate is used alone or with other medications to treat certain types of seizures including primary generalized tonic-clonic seizures (formerly known as a grand mal seizure; seizure that involves the entire body) and partial onset seizures (seizures that involve only one part of the brain). Topiramate is also used with other medications to control seizures in people who have Lennox-Gastaut syndrome (a disorder that causes seizures and developmental delays). Topiramate is also used to prevent migraine headaches but not to relieve the pain of migraine headaches when they occur. Topiramate is in a class of medications called anticonvulsants. It works by decreasing abnormal excitement in the brain.
Related Packages: 68382-0864-77Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Topiramate
Product Information
| NDC | 68382-0864 |
|---|---|
| Product ID | 68382-864_e0c15ca7-80f7-4b91-b6bb-b3f552c8c647 |
| Associated GPIs | |
| GCN Sequence Number | 071344 |
| GCN Sequence Number Description | topiramate CAP ER 24H 50 MG ORAL |
| HIC3 | H4B |
| HIC3 Description | ANTICONVULSANTS |
| GCN | 35104 |
| HICL Sequence Number | 011060 |
| HICL Sequence Number Description | TOPIRAMATE |
| Brand/Generic | Generic |
| Proprietary Name | Topiramate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Topiramate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/1 |
| Substance Name | TOPIRAMATE |
| Labeler Name | Zydus Pharmaceuticals USA Inc. |
| Pharmaceutical Class | Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA207382 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 68382-0864-77 (68382086477)
| NDC Package Code | 68382-864-77 |
|---|---|
| Billing NDC | 68382086477 |
| Package | 10 BLISTER PACK in 1 CARTON (68382-864-77) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-864-30) |
| Marketing Start Date | 2018-04-05 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |