Levalbuterol

Product NDC
0093-4146
11-digit product format
000934146
Labeler code
0093
Product ID
0093-4146_c4bbe9ea-2824-4b67-8557-830bbb80ba5d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levalbuterol
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA090297
Marketing category
ANDA
Marketing start
2013-04-29
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090297-001LEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATIONANRS2013-04-26caaa826d4ba7…
2026-08-18 06:07:402026-07A090297-002LEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATIONANRS2013-04-26caaa826d4ba7…
2026-08-18 06:07:402026-07A090297-003LEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATIONANRS2013-04-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090297-001LEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATIONANRS2013-04-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090297-002LEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATIONANRS2013-04-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090297-003LEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATIONANRS2013-04-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090297-001LEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATIONANRS2013-04-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090297-002LEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATIONANRS2013-04-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090297-003LEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATIONANRS2013-04-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A090297-001LEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATIONANRS2013-04-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090297-002LEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATIONANRS2013-04-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090297-003LEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATIONANRS2013-04-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090297-001LEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATIONANRS2013-04-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090297-002LEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATIONANRS2013-04-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090297-003LEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATIONANRS2013-04-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090297-001LEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATIONANRS2013-04-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090297-002LEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATIONANRS2013-04-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090297-003LEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATIONANRS2013-04-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090297-001LEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATIONANRS2013-04-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090297-002LEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATIONANRS2013-04-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090297-003LEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATIONANRS2013-04-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090297-001LEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATIONANRS2013-04-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090297-002LEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATIONANRS2013-04-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090297-003LEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATIONANRS2013-04-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090297-001LEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATIONANRS2013-04-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090297-002LEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATIONANRS2013-04-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090297-003LEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATIONANRS2013-04-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090297-001LEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATIONANRS2013-04-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090297-002LEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATIONANRS2013-04-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090297-003LEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATIONANRS2013-04-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090297-001LEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATIONANRS2013-04-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A090297-002LEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATIONANRS2013-04-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A090297-003LEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATIONANRS2013-04-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090297-001LEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATIONANRS2013-04-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090297-002LEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATIONANRS2013-04-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090297-003LEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATIONANRS2013-04-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090297-001LEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATIONANRS2013-04-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090297-002LEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATIONANRS2013-04-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090297-003LEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATIONANRS2013-04-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090297-001LEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATIONANRS2013-04-261e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A090297-001AN1caaa826d4ba7…
2026-08-18 06:07:402026-07A090297-002AN1caaa826d4ba7…
2026-08-18 06:07:402026-07A090297-003AN1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090297-001AN1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090297-002AN1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090297-003AN1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090297-001AN131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090297-002AN131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090297-003AN131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090297-001AN16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090297-002AN16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090297-003AN16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090297-001AN1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090297-002AN1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090297-003AN1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090297-001AN1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090297-002AN1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090297-003AN1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090297-001AN103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090297-002AN103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090297-003AN103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090297-001AN12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090297-002AN12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090297-003AN12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090297-001AN15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090297-002AN15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090297-003AN15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090297-001AN1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090297-002AN1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090297-003AN1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090297-001AN1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090297-002AN1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090297-003AN1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090297-001AN179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090297-002AN179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090297-003AN179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090297-001AN1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090297-002AN1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090297-003AN1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090297-001AN11e350fbaab3a…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WDQ1526QJMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
242754Internal RxNorm lookup
311286Internal RxNorm lookup
349590Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f3ce78d9-e923-400e-b3cd-3e6124ac7f6dAvailable on FDA.report

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
0093-4146-45Levalbuterol5 in 1 POUCHSOLUTION514
0093-4146-45Levalbuterol3 mL in 1 VIAL, SINGLE-DOSESOLUTION314
0093-4146-56Levalbuterol6 in 1 CARTONSOLUTION614

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-4146-04ML - Milliliter0093-4146838065b9-125a-41aa-b9ad-fa7013f287c112013-06-04
0093-4146-45ML - Milliliter0093-4146768745b4-0824-46cf-93c2-00e7774dd6be12019-03-12
0093-4146-56ML - Milliliter0093-414622637ede-22b2-4483-b81c-f11da42fa11f12019-03-12
0093-4146-64ML - Milliliter0093-4146934befc4-75b6-42d2-b7b7-c913a3bf5ca112013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVALBUTEROL HYDROCHLORIDEACTIVE INGREDIENTWDQ1526QJMLEVALBUTEROL SOLUTION [TEVA PHARMACEUTICALS USA INC]5
LEVALBUTEROLACTIVE MOIETYEDN2NBH5SSLEVALBUTEROL SOLUTION [TEVA PHARMACEUTICALS USA INC]5
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KLEVALBUTEROL SOLUTION [TEVA PHARMACEUTICALS USA INC]5
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLEVALBUTEROL SOLUTION [TEVA PHARMACEUTICALS USA INC]5
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFLEVALBUTEROL SOLUTION [TEVA PHARMACEUTICALS USA INC]5
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KLEVALBUTEROL SOLUTION [TEVA PHARMACEUTICALS USA INC]5
WATERINACTIVE INGREDIENT059QF0KO0RLEVALBUTEROL SOLUTION [TEVA PHARMACEUTICALS USA INC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-4146LEVALBUTEROL SOLUTION [TEVA PHARMACEUTICALS USA, INC.]14Current NDC, Legacy NDC, 3 package rows20211016_f3ce78d9-e923-400e-b3cd-3e6124ac7f6d.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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
ndc (product): 0093-4146

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349590levalbuterol HCl 0.31 MG in 3 ML Inhalation SolutionPSNf3ce78d9-e923-400e-b3cd-3e6124ac7f6d14
311286levalbuterol HCl 0.63 MG in 3 ML Inhalation SolutionPSNf3ce78d9-e923-400e-b3cd-3e6124ac7f6d14
242754levalbuterol HCl 1.25 MG in 3 ML Inhalation SolutionPSNf3ce78d9-e923-400e-b3cd-3e6124ac7f6d14
349590levalbuterol 0.103 MG/ML Inhalation SolutionSCDf3ce78d9-e923-400e-b3cd-3e6124ac7f6d14
311286levalbuterol 0.21 MG/ML Inhalation SolutionSCDf3ce78d9-e923-400e-b3cd-3e6124ac7f6d14
242754levalbuterol 0.417 MG/ML Inhalation SolutionSCDf3ce78d9-e923-400e-b3cd-3e6124ac7f6d14
349590levalbuterol 0.31 MG (as levalbuterol HCl 0.36 MG) per 3 ML Inhalation SolutionSYf3ce78d9-e923-400e-b3cd-3e6124ac7f6d14
311286levalbuterol 0.63 MG (as levalbuterol HCl 0.73 MG) per 3 ML Inhalation SolutionSYf3ce78d9-e923-400e-b3cd-3e6124ac7f6d14
242754levalbuterol 1.25 MG (as levalbuterol HCl 1.44 MG) per 3 ML Inhalation SolutionSYf3ce78d9-e923-400e-b3cd-3e6124ac7f6d14
311286levalbuterol HCl 0.63 MG in 3 ML Inhalation SolutionPSN97699821-81f8-4623-8504-e479c0f4b1833
311286levalbuterol 0.21 MG/ML Inhalation SolutionSCD97699821-81f8-4623-8504-e479c0f4b1833
311286levalbuterol 0.63 MG (as levalbuterol HCl 0.73 MG) per 3 ML Inhalation SolutionSY97699821-81f8-4623-8504-e479c0f4b1833

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-4146-45000934146455 in 1 POUCHHistorical
0093-4146-56000934146566 POUCH in 1 CARTON (0093-4146-56) / 5 VIAL, SINGLE-DOSE in 1 POUCH (0093-4146-45) / 3 mL in 1 VIAL, SINGLE-DOSE6 pouch2019-01-070000-00-00NoNoCurrent