FDA.reportPublic FDA data

levalbuterol inhalation

Product NDC
43598-409
Requested package NDC
43598-409-25
11-digit product format
435980409
Labeler code
43598
Product ID
43598-409_3ec07be3-1e04-66a2-ffee-b4795006fae9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levalbuterol inhalation 1.25mg/3mL
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Dr. Reddy
Application
ANDA078171
Marketing category
ANDA
Marketing start
2014-09-16
Marketing end
0000-00-00
Substance
LEVALBUTEROL
Active strength
1 mg/3mL
Pharmacologic classes
Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage43598-40943598-409-25DDiscontinued 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
A078171-001LEVALBUTEROL HYDROCHLORIDELEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATIONAN2013-12-13
A078171-002LEVALBUTEROL HYDROCHLORIDELEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATIONAN2013-12-13
A078171-003LEVALBUTEROL HYDROCHLORIDELEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATIONAN2013-12-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078171-001AN
A078171-002AN
A078171-003AN

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 22:54:322026-06A078171-001LEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATIONAN2013-12-13a50c72e98297…
2026-08-01 22:54:322026-06A078171-002LEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATIONAN2013-12-13a50c72e98297…
2026-08-01 22:54:322026-06A078171-003LEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATIONAN2013-12-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078171-001AN1a50c72e98297…
2026-08-01 22:54:322026-06A078171-002AN1a50c72e98297…
2026-08-01 22:54:322026-06A078171-003AN1a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-409-25ML - Milliliter43598-409c9bd88c9-ec5b-4c10-abe2-507c7bd4c30212014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LevalbuterolACTIVE INGREDIENTEDN2NBH5SSLEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.31MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.63MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 1.25MG/3ML) SOLUTION [DR. REDDY’S LABORATORIES, INC.]2
LevalbuterolACTIVE MOIETYEDN2NBH5SSLEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.31MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.63MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 1.25MG/3ML) SOLUTION [DR. REDDY’S LABORATORIES, INC.]2
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KLEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.31MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.63MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 1.25MG/3ML) SOLUTION [DR. REDDY’S LABORATORIES, INC.]2
NitrogenINACTIVE INGREDIENTN762921K75LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.31MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.63MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 1.25MG/3ML) SOLUTION [DR. REDDY’S LABORATORIES, INC.]2
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XLEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.31MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.63MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 1.25MG/3ML) SOLUTION [DR. REDDY’S LABORATORIES, INC.]2
Sulfuric AcidINACTIVE INGREDIENTO40UQP6WCFLEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.31MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.63MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 1.25MG/3ML) SOLUTION [DR. REDDY’S LABORATORIES, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RLEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.31MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.63MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 1.25MG/3ML) SOLUTION [DR. REDDY’S LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-409LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.31MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.63MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 1.25MG/3ML) SOLUTION [DR. REDDY’S LABORATORIES, INC.]4Legacy NDC20241222_163dfa7c-aad3-4290-9fe9-d9592b0ba317.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-409-25435980409255 POUCH in 1 CARTON (43598-409-25) > 5 VIAL in 1 POUCH (43598-409-05) > 3 mL in 1 VIAL5 pouch2014-09-160000-00-00NoNoCurrent