FDA.reportPublic FDA data

Levalbuterol

Product NDC
0093-4147
Requested package NDC
0093-4147-56
11-digit product format
000934147
Labeler code
0093
Product ID
0093-4147_9991cb94-c878-4ec9-aacd-8a2534ac60c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levalbuterol
Dosage form
SOLUTION, CONCENTRATE
Route
RESPIRATORY (INHALATION)
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA200875
Marketing category
ANDA
Marketing start
2014-12-16
Marketing end
0000-00-00
Substance
LEVALBUTEROL HYDROCHLORIDE
Active strength
1 mg/.5mL
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 packagepackage0093-41470093-4147-56DDiscontinued by firm2026-08-03

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A200875-001LEVALBUTEROL HYDROCHLORIDELEVALBUTEROL HYDROCHLORIDEEQ 0.25% BASESOLUTION / INHALATIONAN2014-09-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A200875-001AN

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 22:54:322026-06A200875-001LEVALBUTEROL HYDROCHLORIDEEQ 0.25% BASESOLUTION / INHALATIONAN2014-09-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A200875-001AN1a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-4147-19EA - Each0093-414735f55bf3-dd80-4286-9874-7e478f942e1d12015-01-05
0093-4147-56EA - Each0093-414736e65e09-957c-4ed6-b93c-8ecff297cb3d12015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVALBUTEROL HYDROCHLORIDEACTIVE INGREDIENTWDQ1526QJMLEVALBUTEROL SOLUTION, CONCENTRATE [TEVA PHARMACEUTICALS USA INC]4
LEVALBUTEROLACTIVE MOIETYEDN2NBH5SSLEVALBUTEROL SOLUTION, CONCENTRATE [TEVA PHARMACEUTICALS USA INC]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KLEVALBUTEROL SOLUTION, CONCENTRATE [TEVA PHARMACEUTICALS USA INC]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLEVALBUTEROL SOLUTION, CONCENTRATE [TEVA PHARMACEUTICALS USA INC]4
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFLEVALBUTEROL SOLUTION, CONCENTRATE [TEVA PHARMACEUTICALS USA INC]4
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KLEVALBUTEROL SOLUTION, CONCENTRATE [TEVA PHARMACEUTICALS USA INC]4
WATERINACTIVE INGREDIENT059QF0KO0RLEVALBUTEROL SOLUTION, CONCENTRATE [TEVA PHARMACEUTICALS USA INC]4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-4147-560009341475630 POUCH in 1 CARTON (0093-4147-56) > 1 VIAL, SINGLE-DOSE in 1 POUCH (0093-4147-19) > .5 mL in 1 VIAL, SINGLE-DOSE30 pouch2014-12-160000-00-00NoNoCurrent