FDA.reportPublic FDA data

Levalbuterol

Product NDC
70518-2760
Requested package NDC
70518-2760-0
11-digit product format
705182760
Labeler code
70518
Product ID
70518-2760_d6e8466e-7189-d436-e053-2995a90a68f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levalbuterol
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
REMEDYREPACK INC.
Application
ANDA090297
Marketing category
ANDA
Marketing start
2020-05-29
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
2023-12-31
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 packagepackage70518-276070518-2760-0DDiscontinued by firm2026-07-31

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
A090297-001LEVALBUTEROL HYDROCHLORIDELEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATIONANRS2013-04-26
A090297-002LEVALBUTEROL HYDROCHLORIDELEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATIONANRS2013-04-26
A090297-003LEVALBUTEROL HYDROCHLORIDELEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATIONANRS2013-04-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A090297-001AN
A090297-002AN
A090297-003AN

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 22:54:322026-06A090297-001LEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATIONANRS2013-04-26a50c72e98297…
2026-08-01 22:54:322026-06A090297-002LEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATIONANRS2013-04-26a50c72e98297…
2026-08-01 22:54:322026-06A090297-003LEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATIONANRS2013-04-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090297-001AN1a50c72e98297…
2026-08-01 22:54:322026-06A090297-002AN1a50c72e98297…
2026-08-01 22:54:322026-06A090297-003AN1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevalbuterolLEVALBUTEROLProficient Rx LP97699821-81f8-4623-8504-e479c0f4b1832019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090297
application number: ANDA090297
LevalbuterolLEVALBUTEROLTeva Pharmaceuticals USA, Inc.f3ce78d9-e923-400e-b3cd-3e6124ac7f6d2019-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090297
application number: ANDA090297

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2760-02022-01-31C16284748780-1d6a99b39-9639-a426-e053-dadaa90af4c2These 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
70518-2760-02022-01-28C16284748780-1d6a99b39-9639-a426-e053-dadaa90af4c2These 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2760-0705182760006 POUCH in 1 CARTON (70518-2760-0) > 5 VIAL, SINGLE-DOSE in 1 POUCH > 3 mL in 1 VIAL, SINGLE-DOSE6 pouch2020-05-290000-00-00NoNoCurrent