FDA.reportPublic FDA data

Xopenex

Product NDC
17478-172
11-digit product format
174780172
Labeler code
17478
Product ID
17478-172_74e3a68e-ca3f-45e2-9126-a7a676025e83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levalbuterol Hydrochloride
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Akorn
Application
NDA020837
Marketing category
NDA
Marketing start
2015-02-27
Marketing end
0000-00-00
Substance
LEVALBUTEROL HYDROCHLORIDE
Active strength
0 mg/3mL
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#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3b93cc5d-8105-47d8-8ae6-077d0f655880Product name320190213
415a13b7-458d-4b44-ab20-f56d8ef7ab9dProduct name220170426
a511b237-73ca-80ef-2a42-a935d09028adProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17478-172-242024-01-30C16284748780-11030e365-63af-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use XOPENEX ® Inhalation Solution safely and effectively. See full prescribing information for XOPENEX ® Inhalation Solution. XOPENEX ® (levalbuterol hydrochloride) Inhalation Solution Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17478-172-12Xopenex3 mL in 1 VIAL, SINGLE-DOSESOLUTION37
17478-172-12Xopenex12 in 1 POUCHSOLUTION127
17478-172-24Xopenex2 in 1 CARTONSOLUTION27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-172-12ML - Milliliter17478-172c9d83040-e703-4b11-9048-a9b52e7a811112016-05-16
17478-172-24ML - Milliliter17478-172a9d9b396-43d4-40f6-a8d0-844d43e2505412016-05-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Levalbuterol HydrochlorideACTIVE INGREDIENTWDQ1526QJMXOPENEX (LEVALBUTEROL HYDROCHLORIDE) SOLUTION [AKORN, INC.]1
LevalbuterolACTIVE MOIETYEDN2NBH5SSXOPENEX (LEVALBUTEROL HYDROCHLORIDE) SOLUTION [AKORN, INC.]1
NitrogenINACTIVE INGREDIENTN762921K75XOPENEX (LEVALBUTEROL HYDROCHLORIDE) SOLUTION [AKORN, INC.]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XXOPENEX (LEVALBUTEROL HYDROCHLORIDE) SOLUTION [AKORN, INC.]1
Sulfuric AcidINACTIVE INGREDIENTO40UQP6WCFXOPENEX (LEVALBUTEROL HYDROCHLORIDE) SOLUTION [AKORN, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RXOPENEX (LEVALBUTEROL HYDROCHLORIDE) SOLUTION [AKORN, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17478-172XOPENEX (LEVALBUTEROL HYDROCHLORIDE) SOLUTION [AKORN]7Legacy NDC, 3 package rows20220919_7e2644e6-36c5-4988-8e52-bec90e2cd2f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349590levalbuterol HCl 0.31 MG in 3 ML Inhalation SolutionPSN7e2644e6-36c5-4988-8e52-bec90e2cd2f07
311286levalbuterol HCl 0.63 MG in 3 ML Inhalation SolutionPSN7e2644e6-36c5-4988-8e52-bec90e2cd2f07
242754levalbuterol HCl 1.25 MG in 3 ML Inhalation SolutionPSN7e2644e6-36c5-4988-8e52-bec90e2cd2f07
352132Xopenex 0.31 MG in 3 ML Inhalation SolutionPSN7e2644e6-36c5-4988-8e52-bec90e2cd2f07
261136Xopenex 0.63 MG in 3 ML Inhalation SolutionPSN7e2644e6-36c5-4988-8e52-bec90e2cd2f07
833470Xopenex 1.25 MG in 3 ML Inhalation SolutionPSN7e2644e6-36c5-4988-8e52-bec90e2cd2f07
352132levalbuterol 0.103 MG/ML Inhalation Solution [Xopenex]SBD7e2644e6-36c5-4988-8e52-bec90e2cd2f07
261136levalbuterol 0.21 MG/ML Inhalation Solution [Xopenex]SBD7e2644e6-36c5-4988-8e52-bec90e2cd2f07
833470levalbuterol 0.417 MG/ML Inhalation Solution [Xopenex]SBD7e2644e6-36c5-4988-8e52-bec90e2cd2f07
349590levalbuterol 0.103 MG/ML Inhalation SolutionSCD7e2644e6-36c5-4988-8e52-bec90e2cd2f07
311286levalbuterol 0.21 MG/ML Inhalation SolutionSCD7e2644e6-36c5-4988-8e52-bec90e2cd2f07
242754levalbuterol 0.417 MG/ML Inhalation SolutionSCD7e2644e6-36c5-4988-8e52-bec90e2cd2f07
349590levalbuterol 0.31 MG (as levalbuterol HCl 0.36 MG) per 3 ML Inhalation SolutionSY7e2644e6-36c5-4988-8e52-bec90e2cd2f07
311286levalbuterol 0.63 MG (as levalbuterol HCl 0.73 MG) per 3 ML Inhalation SolutionSY7e2644e6-36c5-4988-8e52-bec90e2cd2f07
242754levalbuterol 1.25 MG (as levalbuterol HCl 1.44 MG) per 3 ML Inhalation SolutionSY7e2644e6-36c5-4988-8e52-bec90e2cd2f07
352132Xopenex 0.103 MG/ML Inhalation SolutionSY7e2644e6-36c5-4988-8e52-bec90e2cd2f07
261136Xopenex 0.21 MG/ML Inhalation SolutionSY7e2644e6-36c5-4988-8e52-bec90e2cd2f07
352132Xopenex 0.31 MG (as levalbuterol hydrochloride 0.36 MG) per 3 ML Inhalation SolutionSY7e2644e6-36c5-4988-8e52-bec90e2cd2f07
833470Xopenex 0.417 MG/ML Inhalation SolutionSY7e2644e6-36c5-4988-8e52-bec90e2cd2f07
261136Xopenex 0.63 MG (levalbuterol hydrochloride 0.73 MG) per 3 ML Inhalation SolutionSY7e2644e6-36c5-4988-8e52-bec90e2cd2f07
833470Xopenex 1.25 MG (as levalbuterol hydrochloride 1.44 MG) per 3 ML Inhalation SolutionSY7e2644e6-36c5-4988-8e52-bec90e2cd2f07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17478-172-12174780172123 mL in 1 VIAL, SINGLE-DOSE3 mlHistorical
17478-172-24174780172242 POUCH in 1 CARTON (17478-172-24) > 12 VIAL, SINGLE-DOSE in 1 POUCH (17478-172-12) > 3 mL in 1 VIAL, SINGLE-DOSE2 pouch2015-02-270000-00-00NoNoCurrent