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