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Montelukast Sodium - 0054-0289-13 - (Montelukast Sodium)

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Drug Information of Montelukast Sodium

Product NDC: 0054-0289
Proprietary Name: Montelukast Sodium
Non Proprietary Name: Montelukast Sodium
Active Ingredient(s): 5    mg/1 & nbsp;   Montelukast Sodium
Administration Route(s): ORAL
Dosage Form(s): TABLET, CHEWABLE
Coding System: National Drug Codes(NDC)

Labeler Information of Montelukast Sodium

Product NDC: 0054-0289
Labeler Name: Roxane Laboratories, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA091128
Marketing Category: ANDA
Start Marketing Date: 20120803

Package Information of Montelukast Sodium

Package NDC: 0054-0289-13
Package Description: 30 TABLET, CHEWABLE in 1 BOTTLE (0054-0289-13)

NDC Information of Montelukast Sodium

NDC Code 0054-0289-13
Proprietary Name Montelukast Sodium
Package Description 30 TABLET, CHEWABLE in 1 BOTTLE (0054-0289-13)
Product NDC 0054-0289
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Montelukast Sodium
Dosage Form Name TABLET, CHEWABLE
Route Name ORAL
Start Marketing Date 20120803
Marketing Category Name ANDA
Labeler Name Roxane Laboratories, Inc.
Substance Name MONTELUKAST SODIUM
Strength Number 5
Strength Unit mg/1
Pharmaceutical Classes Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]

Complete Information of Montelukast Sodium


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