FDA.reportPublic FDA data

Levalbuterol

Product NDC
68071-2340
Requested package NDC
68071-2340-5
11-digit product format
680712340
Labeler code
68071
Product ID
68071-2340_ba5fab26-c896-90e1-e053-2a95a90a6437
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levalbuterol
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA207820
Marketing category
ANDA
Marketing start
2020-05-05
Marketing end
0000-00-00
Substance
LEVALBUTEROL HYDROCHLORIDE
Active strength
1 mg/3mL
Pharmacologic classes
Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68071-234068071-2340-5IInactivated by FDA2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207820-001LEVALBUTEROL HYDROCHLORIDELEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATION2018-11-05
A207820-002LEVALBUTEROL HYDROCHLORIDELEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATION2018-11-05
A207820-003LEVALBUTEROL HYDROCHLORIDELEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATION2018-11-05

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A207820-001LEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATION2018-11-05a50c72e98297…
2026-08-01 22:54:322026-06A207820-002LEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATION2018-11-05a50c72e98297…
2026-08-01 22:54:322026-06A207820-003LEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATION2018-11-05a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levalbuterol Inhalation SolutionLEVALBUTEROL INHALATION SOLUTIONSun Pharmaceutical Industries, Inc.85a59e0c-ff09-49a6-b7b8-616e033107b42020-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207820
application number: ANDA207820

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
68071-2340-52023-01-30C16284748780-1f386c64a-3cde-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LEVALBUTEROL INHALATION SOLUTION safely and effectively. See full prescribing information for LEVALBUTEROL INHALATION SOLUTION. LEVALBUTEROL inhalation solution Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2340-5Levalbuterol5 in 1 POUCHSOLUTION51
68071-2340-5Levalbuterol5 in 1 CARTONSOLUTION51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2340LEVALBUTEROL SOLUTION [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 2 package rows20210203_ba5fab26-c897-90e1-e053-2a95a90a6437.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242754levalbuterol HCl 1.25 MG in 3 ML Inhalation SolutionPSNba5fab26-c897-90e1-e053-2a95a90a64371
242754levalbuterol 0.417 MG/ML Inhalation SolutionSCDba5fab26-c897-90e1-e053-2a95a90a64371
242754levalbuterol 1.25 MG (as levalbuterol HCl 1.44 MG) per 3 ML Inhalation SolutionSYba5fab26-c897-90e1-e053-2a95a90a64371

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2340-5680712340055 POUCH in 1 CARTON (68071-2340-5) > 5 VIAL, SINGLE-DOSE in 1 POUCH > 3 mL in 1 VIAL, SINGLE-DOSE5 pouch2021-02-020000-00-00NoNoCurrent