Product NDC: | 0078-0619 |
Proprietary Name: | Arcapta Neohaler |
Non Proprietary Name: | Indacaterol maleate |
Active Ingredient(s): | 75 ug/1 & nbsp; Indacaterol maleate |
Administration Route(s): | ORAL; RESPIRATORY (INHALATION) |
Dosage Form(s): | CAPSULE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0078-0619 |
Labeler Name: | Novartis Pharmaceuticals Corporation |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA022383 |
Marketing Category: | NDA |
Start Marketing Date: | 20110701 |
Package NDC: | 0078-0619-15 |
Package Description: | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (0078-0619-15) > 1 CAPSULE in 1 BLISTER PACK (0078-0619-61) |
NDC Code | 0078-0619-15 |
Proprietary Name | Arcapta Neohaler |
Package Description | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (0078-0619-15) > 1 CAPSULE in 1 BLISTER PACK (0078-0619-61) |
Product NDC | 0078-0619 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Indacaterol maleate |
Dosage Form Name | CAPSULE |
Route Name | ORAL; RESPIRATORY (INHALATION) |
Start Marketing Date | 20110701 |
Marketing Category Name | NDA |
Labeler Name | Novartis Pharmaceuticals Corporation |
Substance Name | INDACATEROL MALEATE |
Strength Number | 75 |
Strength Unit | ug/1 |
Pharmaceutical Classes |