Ambien - zolpidem tartrate
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Field |
Value |
NDC Code: |
49999-764 |
Proprietary Name: |
Ambien |
Suffix: |
CR |
Non-Proprietary Name: |
zolpidem tartrate |
Dosage Form: |
TABLET |
Method: |
ORAL |
Original Marketing Date: |
10-11-2011 |
Category Name: |
NDA |
Application Number: |
NDA021774 |
Labeler: |
LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC |
Substance Name: |
ZOLPIDEM TARTRATE |
Active Numerator Strength: |
6.25 |
Active Ingredient Unit: |
mg/1 |
Pharm Classes: |
gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] |
DEA Schedule: |
CIV |