Xopenex HFA
- Product NDC
- 63402-510
- 11-digit product format
- 634020510
- Labeler code
- 63402
- Product ID
- 63402-510_bdfdcf19-9165-4b49-9cf2-505e7c107e57
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levalbuterol tartrate
- Dosage form
- AEROSOL, METERED
- Route
- ORAL
- Labeler
- Sunovion Pharmaceuticals Inc.
- Application
- NDA021730
- Marketing category
- NDA
- Marketing start
- 2005-12-01
- Marketing end
- 0000-00-00
- Substance
- LEVALBUTEROL TARTRATE
- Active strength
- 45 ug/1
- Pharmacologic classes
- Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| levalbuterol tartrate | ACTIVE INGREDIENT | ADS4I3E22M | XOPENEX HFA (LEVALBUTEROL TARTRATE) AEROSOL, METERED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| levalbuterol | ACTIVE MOIETY | EDN2NBH5SS | XOPENEX HFA (LEVALBUTEROL TARTRATE) AEROSOL, METERED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| Alcohol | INACTIVE INGREDIENT | 3K9958V90M | XOPENEX HFA (LEVALBUTEROL TARTRATE) AEROSOL, METERED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| norflurane | INACTIVE INGREDIENT | DH9E53K1Y8 | XOPENEX HFA (LEVALBUTEROL TARTRATE) AEROSOL, METERED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| Oleic Acid | INACTIVE INGREDIENT | 2UMI9U37CP | XOPENEX HFA (LEVALBUTEROL TARTRATE) AEROSOL, METERED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63402-510-01 | 63402051001 | 1 INHALER in 1 CARTON (63402-510-01) > 200 AEROSOL, METERED in 1 INHALER | 1 inhaler | 2005-12-01 | 0000-00-00 | No | No | Current |