AMBIEN - 16590-436-60 - (ZOLPIDEM TARTRATE)

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Drug Information of AMBIEN

Product NDC: 16590-436
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)

Labeler Information of AMBIEN

Product NDC: 16590-436
Labeler Name: STAT Rx USA LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA021774
Marketing Category: NDA
Start Marketing Date: 20090630

Package Information of AMBIEN

Package NDC: 16590-436-60
Package Description: 60 TABLET, COATED in 1 BOTTLE (16590-436-60)

NDC Information of AMBIEN

NDC Code 16590-436-60
Proprietary Name AMBIEN
Package Description 60 TABLET, COATED in 1 BOTTLE (16590-436-60)
Product NDC 16590-436
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 STAT Rx USA 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]

Complete Information of AMBIEN


General Information