Product NDC: | 49999-533 |
Proprietary Name: | SINGULAIR |
Non Proprietary Name: | montelukast sodium |
Active Ingredient(s): | 10 mg/1 & nbsp; montelukast sodium |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, FILM COATED |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 49999-533 |
Labeler Name: | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA020829 |
Marketing Category: | NDA |
Start Marketing Date: | 20120321 |
Package NDC: | 49999-533-90 |
Package Description: | 90 TABLET, FILM COATED in 1 BOTTLE (49999-533-90) |
NDC Code | 49999-533-90 |
Proprietary Name | SINGULAIR |
Package Description | 90 TABLET, FILM COATED in 1 BOTTLE (49999-533-90) |
Product NDC | 49999-533 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | montelukast sodium |
Dosage Form Name | TABLET, FILM COATED |
Route Name | ORAL |
Start Marketing Date | 20120321 |
Marketing Category Name | NDA |
Labeler Name | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC |
Substance Name | MONTELUKAST SODIUM |
Strength Number | 10 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] |