ARCAPTA NEOHALER is a Oral; Respiratory (inhalation) Capsule in the Human Prescription Drug category. It is labeled and distributed by Sunovion Pharmaceuticals Inc.. The primary component is Indacaterol Maleate.
| Product ID | 63402-675_1250b6c5-cdae-4771-ae60-1463c97cecca |
| NDC | 63402-675 |
| Product Type | Human Prescription Drug |
| Proprietary Name | ARCAPTA NEOHALER |
| Generic Name | Indacaterol Maleate |
| Dosage Form | Capsule |
| Route of Administration | ORAL; RESPIRATORY (INHALATION) |
| Marketing Start Date | 2011-07-01 |
| Marketing End Date | 2021-01-31 |
| Marketing Category | NDA / NDA |
| Application Number | NDA022383 |
| Labeler Name | Sunovion Pharmaceuticals Inc. |
| Substance Name | INDACATEROL MALEATE |
| Active Ingredient Strength | 75 ug/1 |
| Pharm Classes | Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] |
| NDC Exclude Flag | N |
| Marketing Start Date | 2017-06-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | NDA |
| Application Number | NDA022383 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2011-07-01 |
| Marketing End Date | 2021-01-31 |
| Marketing Category | NDA |
| Application Number | NDA022383 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-06-01 |
| Marketing End Date | 2021-01-31 |
| Marketing Category | NDA |
| Application Number | NDA022383 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2011-07-01 |
| Marketing End Date | 2021-01-31 |
| Marketing Category | NDA |
| Application Number | NDA022383 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-06-01 |
| Marketing End Date | 2021-01-31 |
| Ingredient | Strength |
|---|---|
| INDACATEROL MALEATE | 75 ug/1 |
| SPL SET ID: | e82416ba-23b9-4d40-a41d-baba8e11751b |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |