Xopenex
- Product NDC
- 17478-171
- 11-digit product format
- 174780171
- Labeler code
- 17478
- Product ID
- 17478-171_cf6a4b53-3394-422d-a2e9-1bf2e1cf351d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levalbuterol Hydrochloride
- Dosage form
- SOLUTION, CONCENTRATE
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Akorn
- Application
- NDA020837
- Marketing category
- NDA
- Marketing start
- 2015-02-26
- Marketing end
- 0000-00-00
- Substance
- LEVALBUTEROL HYDROCHLORIDE
- Active strength
- 1 mg/.5mL
- Pharmacologic classes
- Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 17478-171-01 | Xopenex | 1 in 1 POUCH | SOLUTION, CONCENTRATE | 1 | | 8 |
| 17478-171-01 | Xopenex | 0.5 mL in 1 VIAL, SINGLE-DOSE | SOLUTION, CONCENTRATE | 0.5 | | 8 |
| 17478-171-30 | Xopenex | 30 in 1 CARTON | SOLUTION, CONCENTRATE | 30 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Levalbuterol Hydrochloride | ACTIVE INGREDIENT | WDQ1526QJM | XOPENEX (LEVALBUTEROL HYDROCHLORIDE) SOLUTION, CONCENTRATE [AKORN, INC.] | 1 | |
| Levalbuterol | ACTIVE MOIETY | EDN2NBH5SS | XOPENEX (LEVALBUTEROL HYDROCHLORIDE) SOLUTION, CONCENTRATE [AKORN, INC.] | 1 | |
| Hydrochloric Acid | INACTIVE INGREDIENT | QTT17582CB | XOPENEX (LEVALBUTEROL HYDROCHLORIDE) SOLUTION, CONCENTRATE [AKORN, INC.] | 1 | |
| Nitrogen | INACTIVE INGREDIENT | N762921K75 | XOPENEX (LEVALBUTEROL HYDROCHLORIDE) SOLUTION, CONCENTRATE [AKORN, INC.] | 1 | |
| Sodium Chloride | INACTIVE INGREDIENT | 451W47IQ8X | XOPENEX (LEVALBUTEROL HYDROCHLORIDE) SOLUTION, CONCENTRATE [AKORN, INC.] | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | XOPENEX (LEVALBUTEROL HYDROCHLORIDE) SOLUTION, CONCENTRATE [AKORN, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 17478-171 | XOPENEX (LEVALBUTEROL HYDROCHLORIDE) SOLUTION, CONCENTRATE [AKORN] | 8 | Legacy NDC, 3 package rows | 20220919_0c47c47d-45f7-4eb4-b1f8-7d6c633a1f69.zip |
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 |
|---|
| 17478-171-01 | 17478017101 | 1 in 1 POUCH | | | | | | Historical |
| 17478-171-30 | 17478017130 | 30 POUCH in 1 CARTON (17478-171-30) > 1 VIAL, SINGLE-DOSE in 1 POUCH (17478-171-01) > .5 mL in 1 VIAL, SINGLE-DOSE | 30 pouch | 2015-02-26 | 0000-00-00 | No | No | Current |