SINGULAIR - 52125-005-02 - (montelukast sodium)

Alphabetical Index


Drug Information of SINGULAIR

Product NDC: 52125-005
Proprietary Name: SINGULAIR
Non Proprietary Name: montelukast sodium
Active Ingredient(s): 5    mg/1 & nbsp;   montelukast sodium
Administration Route(s): ORAL
Dosage Form(s): GRANULE
Coding System: National Drug Codes(NDC)

Labeler Information of SINGULAIR

Product NDC: 52125-005
Labeler Name: REMEDYREPACK INC.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA021409
Marketing Category: NDA
Start Marketing Date: 20130226

Package Information of SINGULAIR

Package NDC: 52125-005-02
Package Description: 30 GRANULE in 1 BLISTER PACK (52125-005-02)

NDC Information of SINGULAIR

NDC Code 52125-005-02
Proprietary Name SINGULAIR
Package Description 30 GRANULE in 1 BLISTER PACK (52125-005-02)
Product NDC 52125-005
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name montelukast sodium
Dosage Form Name GRANULE
Route Name ORAL
Start Marketing Date 20130226
Marketing Category Name NDA
Labeler Name REMEDYREPACK 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 SINGULAIR


General Information