FDA.reportPublic FDA data

LEVALBUTEROL

Product NDC
65862-942
11-digit product format
658620942
Labeler code
65862
Product ID
65862-942_08fe55b3-a3cd-d8cf-e063-6394a90a1a95
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVALBUTEROL
Dosage form
SOLUTION, CONCENTRATE
Route
RESPIRATORY (INHALATION)
Labeler
Aurobindo Pharma Limited
Application
ANDA207628
Marketing category
ANDA
Marketing start
2017-01-31
Substance
LEVALBUTEROL HYDROCHLORIDE
Active strength
1.25 mg/.5mL
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
LEVALBUTEROL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVALBUTEROL HYDROCHLORIDE1.25 mg/.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWDQ1526QJM
Rxcui1855389

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
65862-942-03LEVALBUTEROL30 in 1 CARTONSOLUTION, CONCENTRATE306
65862-942-50LEVALBUTEROL0.5 mL in 1 VIAL, SINGLE-DOSESOLUTION, CONCENTRATE0.56
65862-942-50LEVALBUTEROL1 in 1 POUCHSOLUTION, CONCENTRATE16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-942-03EA - Each65862-9427080ab7c-5072-43ac-9651-790ecbe8dccd12018-01-12
65862-942-50EA - Each65862-94217254e96-0d10-451e-8720-e922447d846712018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-942LEVALBUTEROL (LEVALBUTEROL) SOLUTION, CONCENTRATE [AUROBINDO PHARMA LIMITED]6Current NDC, Legacy NDC, 3 package rows20231031_e1a9effb-6ef7-4651-b0ef-a9265600caff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1855389levalbuterol HCl concentrate 1.25 MG in 0.5 ML Inhalation SolutionPSNe1a9effb-6ef7-4651-b0ef-a9265600caff6
1855389levalbuterol 2.5 MG/ML Inhalation SolutionSCDe1a9effb-6ef7-4651-b0ef-a9265600caff6
1855389levalbuterol HCl 1.25 MG per 0.5 ML Inhalation SolutionSYe1a9effb-6ef7-4651-b0ef-a9265600caff6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-942-036586209420330 POUCH in 1 CARTON (65862-942-03) / 1 VIAL, SINGLE-DOSE in 1 POUCH (65862-942-50) / .5 mL in 1 VIAL, SINGLE-DOSE30 pouch2017-01-310000-00-00NoNoCurrent
65862-942-50658620942500.5 mL in 1 VIAL, SINGLE-DOSE0.5 mlHistorical