Product NDC: | 21695-213 |
Proprietary Name: | Ambien CR |
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: | 21695-213 |
Labeler Name: | Rebel Distributors Corp. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA021774 |
Marketing Category: | NDA |
Start Marketing Date: | 20090630 |
Package NDC: | 21695-213-15 |
Package Description: | 15 TABLET, COATED in 1 BOTTLE (21695-213-15) |
NDC Code | 21695-213-15 |
Proprietary Name | Ambien CR |
Package Description | 15 TABLET, COATED in 1 BOTTLE (21695-213-15) |
Product NDC | 21695-213 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | zolpidem tartrate |
Dosage Form Name | TABLET, COATED |
Route Name | ORAL |
Start Marketing Date | 20090630 |
Marketing Category Name | NDA |
Labeler Name | Rebel Distributors Corp. |
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] |