Modafinil - 0378-5575-01 - (modafinil)

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Drug Information of Modafinil

Product NDC: 0378-5575
Proprietary Name: Modafinil
Non Proprietary Name: modafinil
Active Ingredient(s): 200    mg/1 & nbsp;   modafinil
Administration Route(s): ORAL
Dosage Form(s): TABLET
Coding System: National Drug Codes(NDC)

Labeler Information of Modafinil

Product NDC: 0378-5575
Labeler Name: Mylan Pharmaceuticals Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA076594
Marketing Category: ANDA
Start Marketing Date: 20130117

Package Information of Modafinil

Package NDC: 0378-5575-01
Package Description: 100 TABLET in 1 BOTTLE, PLASTIC (0378-5575-01)

NDC Information of Modafinil

NDC Code 0378-5575-01
Proprietary Name Modafinil
Package Description 100 TABLET in 1 BOTTLE, PLASTIC (0378-5575-01)
Product NDC 0378-5575
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name modafinil
Dosage Form Name TABLET
Route Name ORAL
Start Marketing Date 20130117
Marketing Category Name ANDA
Labeler Name Mylan Pharmaceuticals Inc.
Substance Name MODAFINIL
Strength Number 200
Strength Unit mg/1
Pharmaceutical Classes Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC]

Complete Information of Modafinil


General Information