Product NDC: | 0781-5315 |
Proprietary Name: | Zolpidem tartrate |
Non Proprietary Name: | Zolpidem tartrate |
Active Ingredient(s): | 6.25 mg/1 & nbsp; Zolpidem tartrate |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, EXTENDED RELEASE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0781-5315 |
Labeler Name: | Sandoz Inc |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA090107 |
Marketing Category: | ANDA |
Start Marketing Date: | 20111031 |
Package NDC: | 0781-5315-05 |
Package Description: | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5315-05) |
NDC Code | 0781-5315-05 |
Proprietary Name | Zolpidem tartrate |
Package Description | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5315-05) |
Product NDC | 0781-5315 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Zolpidem tartrate |
Dosage Form Name | TABLET, EXTENDED RELEASE |
Route Name | ORAL |
Start Marketing Date | 20111031 |
Marketing Category Name | ANDA |
Labeler Name | Sandoz Inc |
Substance Name | ZOLPIDEM TARTRATE |
Strength Number | 6.25 |
Strength Unit | mg/1 |
Pharmaceutical Classes | gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] |