Product NDC: | 0024-5521 |
Proprietary Name: | Ambien |
Non Proprietary Name: | zolpidem tartrate |
Active Ingredient(s): | 12.5 mg/1 & nbsp; zolpidem tartrate |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, COATED |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0024-5521 |
Labeler Name: | sanofi-aventis U.S. LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA021774 |
Marketing Category: | NDA |
Start Marketing Date: | 20050919 |
Package NDC: | 0024-5521-10 |
Package Description: | 3 BLISTER PACK in 1 CARTON (0024-5521-10) > 10 TABLET, COATED in 1 BLISTER PACK |
NDC Code | 0024-5521-10 |
Proprietary Name | Ambien |
Package Description | 3 BLISTER PACK in 1 CARTON (0024-5521-10) > 10 TABLET, COATED in 1 BLISTER PACK |
Product NDC | 0024-5521 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | zolpidem tartrate |
Dosage Form Name | TABLET, COATED |
Route Name | ORAL |
Start Marketing Date | 20050919 |
Marketing Category Name | NDA |
Labeler Name | sanofi-aventis U.S. LLC |
Substance Name | ZOLPIDEM TARTRATE |
Strength Number | 12.5 |
Strength Unit | mg/1 |
Pharmaceutical Classes | gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] |