Xopenex HFA is a Oral Aerosol, Metered in the Human Prescription Drug category. It is labeled and distributed by Sunovion Pharmaceuticals Inc.. The primary component is Levalbuterol Tartrate.
Product ID | 63402-510_93390d71-9fb2-497a-a1b6-b1ce6178430c |
NDC | 63402-510 |
Product Type | Human Prescription Drug |
Proprietary Name | Xopenex HFA |
Generic Name | Levalbuterol Tartrate |
Dosage Form | Aerosol, Metered |
Route of Administration | ORAL |
Marketing Start Date | 2005-12-01 |
Marketing Category | NDA / NDA |
Application Number | NDA021730 |
Labeler Name | Sunovion Pharmaceuticals Inc. |
Substance Name | LEVALBUTEROL TARTRATE |
Active Ingredient Strength | 45 ug/1 |
Pharm Classes | Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] |
NDC Exclude Flag | N |
Listing Certified Through | 2020-12-31 |
Marketing Start Date | 2005-12-01 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | NDA |
Application Number | NDA021730 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | GM |
Marketing Start Date | 2005-12-01 |
Marketing Category | NDA |
Application Number | NDA021730 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2008-04-01 |
Marketing End Date | 2008-04-01 |
Marketing Category | NDA |
Application Number | NDA021730 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2010-06-11 |
Marketing End Date | 2011-12-22 |
Marketing Category | NDA |
Application Number | NDA021730 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2008-04-01 |
Marketing End Date | 2015-02-28 |
Ingredient | Strength |
---|---|
LEVALBUTEROL TARTRATE | 45 ug/1 |
SPL SET ID: | 218ab3f0-4d1e-4c33-a7e8-27807f029d83 |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI | |
UPC Code |
NDC | Brand Name | Generic Name |
---|---|---|
63402-510 | Xopenex HFA | levalbuterol tartrate |
0591-2927 | Levalbuterol tartrate HFA inhalation | levalbuterol tartrate |
63187-876 | Levalbuterol tartrate HFA inhalation | levalbuterol tartrate |
63629-8822 | Levalbuterol tartrate HFA inhalation | levalbuterol tartrate |
68788-6845 | Levalbuterol tartrate HFA inhalation | levalbuterol tartrate |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
XOPENEX HFA 78333582 3124312 Live/Registered |
SUNOVION PHARMACEUTICALS INC. 2003-11-26 |