| Product NDC: | 0037-6050 |
| Proprietary Name: | Edluar |
| Non Proprietary Name: | Zolpidem Tartrate |
| Active Ingredient(s): | 5 mg/1 & nbsp; Zolpidem Tartrate |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0037-6050 |
| Labeler Name: | Meda Pharmaceuticals Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021997 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20090724 |
| Package NDC: | 0037-6050-30 |
| Package Description: | 3 BLISTER PACK in 1 CARTON (0037-6050-30) > 10 TABLET in 1 BLISTER PACK |
| NDC Code | 0037-6050-30 |
| Proprietary Name | Edluar |
| Package Description | 3 BLISTER PACK in 1 CARTON (0037-6050-30) > 10 TABLET in 1 BLISTER PACK |
| Product NDC | 0037-6050 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Zolpidem Tartrate |
| Dosage Form Name | TABLET |
| Route Name | ORAL |
| Start Marketing Date | 20090724 |
| Marketing Category Name | NDA |
| Labeler Name | Meda Pharmaceuticals Inc. |
| Substance Name | ZOLPIDEM TARTRATE |
| Strength Number | 5 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] |