| Product NDC: | 54868-3657 | 
| Proprietary Name: | RESTORIL | 
| Non Proprietary Name: | temazepam | 
| Active Ingredient(s): | 7.5 mg/1 & nbsp; temazepam | 
| Administration Route(s): | ORAL | 
| Dosage Form(s): | CAPSULE | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 54868-3657 | 
| Labeler Name: | Physicians Total Care, Inc. | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | NDA018163 | 
| Marketing Category: | NDA | 
| Start Marketing Date: | 20070108 | 
| Package NDC: | 54868-3657-0 | 
| Package Description: | 100 CAPSULE in 1 BOTTLE (54868-3657-0) | 
| NDC Code | 54868-3657-0 | 
| Proprietary Name | RESTORIL | 
| Package Description | 100 CAPSULE in 1 BOTTLE (54868-3657-0) | 
| Product NDC | 54868-3657 | 
| Product Type Name | HUMAN PRESCRIPTION DRUG | 
| Non Proprietary Name | temazepam | 
| Dosage Form Name | CAPSULE | 
| Route Name | ORAL | 
| Start Marketing Date | 20070108 | 
| Marketing Category Name | NDA | 
| Labeler Name | Physicians Total Care, Inc. | 
| Substance Name | TEMAZEPAM | 
| Strength Number | 7.5 | 
| Strength Unit | mg/1 | 
| Pharmaceutical Classes | Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] |