| 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 |