FDA.reportPublic FDA data

XOPENEX HFA

Product NDC
27437-056
11-digit product format
274370056
Labeler code
27437
Product ID
27437-056_905559df-c984-469d-b6b1-a38fdc320471
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levalbuterol tartrate
Dosage form
AEROSOL, METERED
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
NDA021730
Marketing category
NDA
Marketing start
2023-11-10
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
XOPENEX HFA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVALBUTEROL TARTRATE45 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiADS4I3E22M
Rxcui745791, 746466

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27437-056-01XOPENEX HFA1 in 1 CARTONAEROSOL, METERED13
27437-056-01XOPENEX HFA200 in 1 INHALERAEROSOL, METERED2003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27437-056-01GM - Gram27437-056c2778936-5305-4b28-8412-0f48f4aae28e12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27437-056XOPENEX HFA (LEVALBUTEROL TARTRATE) AEROSOL, METERED [LUPIN PHARMACEUTICALS, INC.]2Current NDC, 2 package rows20240316_70a35706-d7a8-4a48-98c6-1cab1c42fe8d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
745791levalbuterol 45 MCG/INHAL Metered Dose Inhaler, 200 ActuationsPSN70a35706-d7a8-4a48-98c6-1cab1c42fe8d3
746466Xopenex HFA 45 MCG/INHAL Metered Dose Inhaler, 200 ActuationsPSN70a35706-d7a8-4a48-98c6-1cab1c42fe8d3
746466200 ACTUAT levalbuterol 0.045 MG/ACTUAT Metered Dose Inhaler [Xopenex]SBD70a35706-d7a8-4a48-98c6-1cab1c42fe8d3
745791200 ACTUAT levalbuterol 0.045 MG/ACTUAT Metered Dose InhalerSCD70a35706-d7a8-4a48-98c6-1cab1c42fe8d3
745791levalbuterol 0.045 MG/ACTUAT Metered Dose Inhaler, 200 ACTUATSY70a35706-d7a8-4a48-98c6-1cab1c42fe8d3
745791levalbuterol 45 MCG/ACTUAT Metered Dose Inhaler, 200 ACTUATSY70a35706-d7a8-4a48-98c6-1cab1c42fe8d3
746466Xopenex 0.045 MG/ACTUAT (levalbuterol tartrate 0.059 MG/ACTUAT) Metered Dose Inhaler, 200 ACTUATSY70a35706-d7a8-4a48-98c6-1cab1c42fe8d3
746466Xopenex 45 MCG/ACTUAT Metered Dose Inhaler, 200 ACTUATSY70a35706-d7a8-4a48-98c6-1cab1c42fe8d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
27437-056-01274370056011 INHALER in 1 CARTON (27437-056-01) / 200 AEROSOL, METERED in 1 INHALER1 inhaler2023-11-10NoNoHistorical