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NDC 63459-0416-30 GABITRIL 16 mg/1 Details
GABITRIL 16 mg/1
GABITRIL is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Cephalon, LLC. The primary component is TIAGABINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Tiagabine is used in combination with other medications to treat partial seizures (a type of epilepsy). Tiagabine is in a class of medications called anticonvulsants. It is not known exactly how tiagabine works, but it increases the amount of natural chemicals in the brain that prevent seizure activity.
Related Packages: 63459-0416-30Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Tiagabine
Product Information
NDC | 63459-0416 |
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Product ID | 63459-416_d7af694a-3367-452e-aeaa-5a529d1dd364 |
Associated GPIs | 72170070100320 |
GCN Sequence Number | 034739 |
GCN Sequence Number Description | tiagabine HCl TABLET 16 MG ORAL |
HIC3 | H4B |
HIC3 Description | ANTICONVULSANTS |
GCN | 37982 |
HICL Sequence Number | 015773 |
HICL Sequence Number Description | TIAGABINE HCL |
Brand/Generic | Brand |
Proprietary Name | GABITRIL |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Tiagabine Hydrochloride |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | TABLET, FILM COATED |
Route | ORAL |
Active Ingredient Strength | 16 |
Active Ingredient Units | mg/1 |
Substance Name | TIAGABINE HYDROCHLORIDE |
Labeler Name | Cephalon, LLC |
Pharmaceutical Class | Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE] |
DEA Schedule | n/a |
Marketing Category | NDA |
Application Number | NDA020646 |
Listing Certified Through | n/a |
Package
NDC 63459-0416-30 (63459041630)
NDC Package Code | 63459-416-30 |
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Billing NDC | 63459041630 |
Package | 30 TABLET, FILM COATED in 1 BOTTLE (63459-416-30) |
Marketing Start Date | 2010-02-08 |
NDC Exclude Flag | N |
Pricing Information | N/A |