| Product NDC: | 55154-7257 |
| 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: | 55154-7257 |
| Labeler Name: | Cardinal Health |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA018163 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20081120 |
| Package NDC: | 55154-7257-4 |
| Package Description: | 100 POUCH in 1 CARTON (55154-7257-4) > 1 CAPSULE in 1 POUCH (55154-7257-6) |
| NDC Code | 55154-7257-4 |
| Proprietary Name | RESTORIL |
| Package Description | 100 POUCH in 1 CARTON (55154-7257-4) > 1 CAPSULE in 1 POUCH (55154-7257-6) |
| Product NDC | 55154-7257 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | temazepam |
| Dosage Form Name | CAPSULE |
| Route Name | ORAL |
| Start Marketing Date | 20081120 |
| Marketing Category Name | NDA |
| Labeler Name | Cardinal Health |
| Substance Name | TEMAZEPAM |
| Strength Number | 7.5 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] |