UTIBRON NEOHALER is a Respiratory (inhalation) Capsule in the Human Prescription Drug category. It is labeled and distributed by Sunovion Pharmaceuticals Inc.. The primary component is Indacaterol Maleate; Glycopyrrolate.
| Product ID | 63402-681_53eb85fe-faf4-49ff-91db-94c158bb4f64 |
| NDC | 63402-681 |
| Product Type | Human Prescription Drug |
| Proprietary Name | UTIBRON NEOHALER |
| Generic Name | Indacaterol Maleate And Glycopyrrolate |
| Dosage Form | Capsule |
| Route of Administration | RESPIRATORY (INHALATION) |
| Marketing Start Date | 2015-10-29 |
| Marketing End Date | 2021-04-30 |
| Marketing Category | NDA / NDA |
| Application Number | NDA207930 |
| Labeler Name | Sunovion Pharmaceuticals Inc. |
| Substance Name | INDACATEROL MALEATE; GLYCOPYRROLATE |
| Active Ingredient Strength | 28 ug/1; ug/1 |
| Pharm Classes | Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA] |
| NDC Exclude Flag | N |
| Marketing Start Date | 2017-12-01 |
| Marketing End Date | 2021-04-30 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | NDA |
| Application Number | NDA207930 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-12-01 |
| Marketing End Date | 2021-04-30 |
| Marketing Category | NDA |
| Application Number | NDA207930 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2015-10-29 |
| Marketing End Date | 2021-04-30 |
| Marketing Category | NDA |
| Application Number | NDA207930 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2015-10-29 |
| Marketing End Date | 2021-04-30 |
| Marketing Category | NDA |
| Application Number | NDA207930 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-12-01 |
| Marketing End Date | 2021-04-30 |
| Marketing Category | NDA |
| Application Number | NDA207930 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-12-01 |
| Marketing End Date | 2021-04-30 |
| Ingredient | Strength |
|---|---|
| INDACATEROL MALEATE | 27.5 ug/1 |
| SPL SET ID: | 7579de3d-caad-4697-b429-760db3e68a23 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0078-0664 | UTIBRON NEOHALER | indacaterol and glycopyrrolate |
| 63402-681 | UTIBRON NEOHALER | INDACATEROL MALEATE and GLYCOPYRROLATE |