| Product NDC: | 35356-372 | 
| Proprietary Name: | PROVIGIL | 
| 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) | 
| Product NDC: | 35356-372 | 
| Labeler Name: | Lake Erie Medical Surgical & Supply DBA Quality Care Products LLC | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | NDA020717 | 
| Marketing Category: | NDA | 
| Start Marketing Date: | 20110720 | 
| Package NDC: | 35356-372-30 | 
| Package Description: | 30 TABLET in 1 BOTTLE (35356-372-30) | 
| NDC Code | 35356-372-30 | 
| Proprietary Name | PROVIGIL | 
| Package Description | 30 TABLET in 1 BOTTLE (35356-372-30) | 
| Product NDC | 35356-372 | 
| Product Type Name | HUMAN PRESCRIPTION DRUG | 
| Non Proprietary Name | modafinil | 
| Dosage Form Name | TABLET | 
| Route Name | ORAL | 
| Start Marketing Date | 20110720 | 
| Marketing Category Name | NDA | 
| Labeler Name | Lake Erie Medical Surgical & Supply DBA Quality Care Products LLC | 
| 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] |