Gabapentin - 0378-5425-01 - (gabapentin)

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Drug Information of Gabapentin

Product NDC: 0378-5425
Proprietary Name: Gabapentin
Non Proprietary Name: gabapentin
Active Ingredient(s): 800    mg/1 & nbsp;   gabapentin
Administration Route(s): ORAL
Dosage Form(s): TABLET
Coding System: National Drug Codes(NDC)

Labeler Information of Gabapentin

Product NDC: 0378-5425
Labeler Name: Mylan Pharmaceuticals Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA090335
Marketing Category: ANDA
Start Marketing Date: 20120626

Package Information of Gabapentin

Package NDC: 0378-5425-01
Package Description: 100 TABLET in 1 BOTTLE, PLASTIC (0378-5425-01)

NDC Information of Gabapentin

NDC Code 0378-5425-01
Proprietary Name Gabapentin
Package Description 100 TABLET in 1 BOTTLE, PLASTIC (0378-5425-01)
Product NDC 0378-5425
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name gabapentin
Dosage Form Name TABLET
Route Name ORAL
Start Marketing Date 20120626
Marketing Category Name ANDA
Labeler Name Mylan Pharmaceuticals Inc.
Substance Name GABAPENTIN
Strength Number 800
Strength Unit mg/1
Pharmaceutical Classes Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]

Complete Information of Gabapentin


General Information