Ambien

See also: Generic Ambien CR

Ambien is a brand name of zolpidem, approved by the FDA in the following formulation(s):

AMBIEN (zolpidem tartrate - tablet; oral)

• 
  Manufacturer: SANOFI AVENTIS US
  
  Approval date: December 16, 1992
  
  Strength(s): 10MG ^[RLD][AB], 5MG ^[AB]

Has a generic version of Ambien been approved?

A generic version of Ambien has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Ambien and have been approved by the FDA:

zolpidem tartrate tablet; oral

• 
  Manufacturer: APOTEX INC
  
  Approval date: April 23, 2007
  
  Strength(s): 10MG ^[AB], 5MG ^[AB]


• 
  Manufacturer: AUROBINDO PHARMA
  
  Approval date: May 4, 2007
  
  Strength(s): 10MG ^[AB], 5MG ^[AB]


• 
  Manufacturer: CARACO
  
  Approval date: April 23, 2007
  
  Strength(s): 10MG ^[AB], 5MG ^[AB]


• 
  Manufacturer: CARLSBAD
  
  Approval date: April 23, 2007
  
  Strength(s): 10MG ^[AB], 5MG ^[AB]


• 
  Manufacturer: DR REDDYS LABS LTD
  
  Approval date: April 23, 2007
  
  Strength(s): 10MG ^[AB], 5MG ^[AB]


• 
  Manufacturer: HIKMA
  
  Approval date: April 30, 2008
  
  Strength(s): 10MG ^[AB], 5MG ^[AB]


• 
  Manufacturer: INVAGEN PHARMS
  
  Approval date: September 7, 2007
  
  Strength(s): 10MG ^[AB], 5MG ^[AB]


• 
  Manufacturer: LEK PHARMS DD
  
  Approval date: April 23, 2007
  
  Strength(s): 10MG ^[AB], 5MG ^[AB]


• 
  Manufacturer: MYLAN
  
  Approval date: April 23, 2007
  
  Strength(s): 10MG ^[AB], 10MG ^[AB], 5MG ^[AB], 5MG ^[AB]


• 
  Manufacturer: RANBAXY
  
  Approval date: April 23, 2007
  
  Strength(s): 10MG ^[AB], 5MG ^[AB]


• 
  Manufacturer: ROXANE
  
  Approval date: April 23, 2007
  
  Strength(s): 10MG ^[AB], 5MG ^[AB]


• 
  Manufacturer: TEVA
  
  Approval date: April 23, 2007
  
  Strength(s): 10MG ^[AB], 5MG ^[AB]


• 
  Manufacturer: TORRENT PHARMS
  
  Approval date: August 17, 2007
  
  Strength(s): 10MG ^[AB], 5MG ^[AB]


• 
  Manufacturer: VINTAGE
  
  Approval date: November 21, 2008
  
  Strength(s): 10MG ^[AB], 5MG ^[AB]


• 
  Manufacturer: WATSON LABS
  
  Approval date: April 23, 2007
  
  Strength(s): 10MG ^[AB], 5MG ^[AB]


• 
  Manufacturer: WOCKHARDT
  
  Approval date: May 15, 2007
  
  Strength(s): 10MG ^[AB], 5MG ^[AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Ambien. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

There are no current U.S. patents associated with Ambien.

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

• Exclusivity expiration dates:
  • September 29, 2010 - PEDIATRIC EXCLUSIVITY
  
  

See also...

• Ambien Consumer Information (Drugs.com)
• Ambien Consumer Information (Wolters Kluwer)
• Ambien Consumer Information (Cerner Multum)
• Ambien Advanced Consumer Information (Micromedex)
• Ambien AHFS DI Monographs (ASHP)
• Zolpidem Consumer Information (Drugs.com)
• Zolpidem Consumer Information (Wolters Kluwer)
• Zolpidem Extended-Release Tablets Consumer Information (Wolters Kluwer)
• Zolpidem Oral Spray Consumer Information (Wolters Kluwer)
• Zolpidem Consumer Information (Cerner Multum)
• Zolpidem Oral, Oromucosal Advanced Consumer Information (Micromedex)
• Zolpidem Tartrate AHFS DI Monographs (ASHP)