FDA.reportPublic FDA data

Levalbuterol

Product NDC
65862-944
11-digit product format
658620944
Labeler code
65862
Product ID
65862-944_29ed39d7-180a-93e4-e063-6294a90a73a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levalbuterol
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Aurobindo Pharma Limited
Application
ANDA207625
Marketing category
ANDA
Marketing start
2016-12-30
Substance
LEVALBUTEROL HYDROCHLORIDE
Active strength
.63 mg/3mL
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 HYDROCHLORIDE.63 mg/3mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWDQ1526QJM
Rxcui242754, 311286, 349590

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
65862-944-05Levalbuterol3 mL in 1 VIAL, SINGLE-DOSESOLUTION38
65862-944-05Levalbuterol5 in 1 POUCHSOLUTION58
65862-944-25Levalbuterol5 in 1 CARTONSOLUTION58

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-944-12ML - Milliliter65862-944259b1cc2-08ff-4309-94d9-037200d4521b12018-01-12
65862-944-24ML - Milliliter65862-94486470ed1-7955-436e-9877-32bf8596c20c12018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-944LEVALBUTEROL SOLUTION [AUROBINDO PHARMA LIMITED]8Current NDC, Legacy NDC, 3 package rows20241226_5f1c4f22-d420-495c-8f64-33532638215f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349590levalbuterol HCl 0.31 MG in 3 ML Inhalation SolutionPSN5f1c4f22-d420-495c-8f64-33532638215f8
311286levalbuterol HCl 0.63 MG in 3 ML Inhalation SolutionPSN5f1c4f22-d420-495c-8f64-33532638215f8
242754levalbuterol HCl 1.25 MG in 3 ML Inhalation SolutionPSN5f1c4f22-d420-495c-8f64-33532638215f8
349590levalbuterol 0.103 MG/ML Inhalation SolutionSCD5f1c4f22-d420-495c-8f64-33532638215f8
311286levalbuterol 0.21 MG/ML Inhalation SolutionSCD5f1c4f22-d420-495c-8f64-33532638215f8
242754levalbuterol 0.417 MG/ML Inhalation SolutionSCD5f1c4f22-d420-495c-8f64-33532638215f8
349590levalbuterol 0.31 MG (as levalbuterol HCl 0.36 MG) per 3 ML Inhalation SolutionSY5f1c4f22-d420-495c-8f64-33532638215f8
311286levalbuterol 0.63 MG (as levalbuterol HCl 0.73 MG) per 3 ML Inhalation SolutionSY5f1c4f22-d420-495c-8f64-33532638215f8
242754levalbuterol 1.25 MG (as levalbuterol HCl 1.44 MG) per 3 ML Inhalation SolutionSY5f1c4f22-d420-495c-8f64-33532638215f8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-944-05658620944053 mL in 1 VIAL, SINGLE-DOSE3 mlHistorical
65862-944-24658620944242 POUCH in 1 CARTON (65862-944-24) > 12 VIAL, SINGLE-DOSE in 1 POUCH (65862-944-12) > 3 mL in 1 VIAL, SINGLE-DOSE2 pouch2016-12-300000-00-00NoNoCurrent
65862-944-25658620944255 POUCH in 1 CARTON (65862-944-25) / 5 VIAL, SINGLE-DOSE in 1 POUCH (65862-944-05) / 3 mL in 1 VIAL, SINGLE-DOSE5 pouch2016-12-30NoNoCurrent