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 |