Levalbuterol

Product NDC
0378-9690
11-digit product format
003789690
Labeler code
0378
Product ID
0378-9690_2f82efe7-5a39-44e6-a7c0-840a60c6246f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levalbuterol
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA203653
Marketing category
ANDA
Marketing start
2018-07-23
Substance
LEVALBUTEROL HYDROCHLORIDE
Active strength
.31 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
A203653-001LEVALBUTEROL HYDROCHLORIDELEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATIONAN2016-03-22
A203653-002LEVALBUTEROL HYDROCHLORIDELEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATIONAN2016-03-22
A203653-003LEVALBUTEROL HYDROCHLORIDELEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATIONAN2016-03-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203653-001AN
A203653-002AN
A203653-003AN

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 06:07:402026-07A203653-001LEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATIONAN2016-03-22caaa826d4ba7…
2026-08-18 06:07:402026-07A203653-002LEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATIONAN2016-03-22caaa826d4ba7…
2026-08-18 06:07:402026-07A203653-003LEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATIONAN2016-03-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203653-001LEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATIONAN2016-03-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203653-002LEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATIONAN2016-03-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203653-003LEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATIONAN2016-03-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203653-001LEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATIONAN2016-03-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203653-002LEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATIONAN2016-03-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203653-003LEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATIONAN2016-03-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A203653-001LEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATIONAN2016-03-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203653-002LEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATIONAN2016-03-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203653-003LEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATIONAN2016-03-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203653-001LEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATIONAN2016-03-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203653-002LEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATIONAN2016-03-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203653-003LEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATIONAN2016-03-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203653-001LEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATIONAN2016-03-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203653-002LEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATIONAN2016-03-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203653-003LEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATIONAN2016-03-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203653-001LEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATIONAN2016-03-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203653-002LEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATIONAN2016-03-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203653-003LEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATIONAN2016-03-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203653-001LEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATIONAN2016-03-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203653-002LEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATIONAN2016-03-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203653-003LEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATIONAN2016-03-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203653-001LEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATIONAN2016-03-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203653-002LEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATIONAN2016-03-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203653-003LEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATIONAN2016-03-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203653-001LEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATIONAN2016-03-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203653-002LEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATIONAN2016-03-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203653-003LEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATIONAN2016-03-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203653-001LEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATIONAN2016-03-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A203653-002LEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATIONAN2016-03-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A203653-003LEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATIONAN2016-03-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203653-001LEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATIONAN2016-03-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203653-002LEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATIONAN2016-03-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203653-003LEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATIONAN2016-03-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203653-001LEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATIONAN2016-03-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203653-002LEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATIONAN2016-03-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203653-003LEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATIONAN2016-03-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203653-001LEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATIONAN2016-03-221e350fbaab3a…

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 06:07:402026-07A203653-001AN1caaa826d4ba7…
2026-08-18 06:07:402026-07A203653-002AN1caaa826d4ba7…
2026-08-18 06:07:402026-07A203653-003AN1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203653-001AN1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203653-002AN1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203653-003AN1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203653-001AN131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203653-002AN131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203653-003AN131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203653-001AN16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203653-002AN16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203653-003AN16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203653-001AN1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203653-002AN1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203653-003AN1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203653-001AN1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203653-002AN1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203653-003AN1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203653-001AN103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203653-002AN103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203653-003AN103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203653-001AN12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203653-002AN12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203653-003AN12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203653-001AN15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203653-002AN15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203653-003AN15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203653-001AN1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203653-002AN1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203653-003AN1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203653-001AN1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203653-002AN1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203653-003AN1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203653-001AN179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203653-002AN179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203653-003AN179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203653-001AN1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203653-002AN1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203653-003AN1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203653-001AN11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Levalbuterol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVALBUTEROL HYDROCHLORIDE.31 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
5b4fa89e-aa46-4504-a275-246f3b4df1dfAvailable 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
0378-9690-52Levalbuterol1 in 1 CARTONSOLUTION14
0378-9690-62Levalbuterol3 mL in 1 AMPULESOLUTION34
0378-9690-62Levalbuterol25 in 1 POUCHSOLUTION254

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-9690-52ML - Milliliter0378-9690d60844c6-dd07-41c2-8bf4-6395dfbab13f12018-08-13
0378-9690-62ML - Milliliter0378-96902afe9b04-2e0a-4f5f-a095-3a4cfa783f0f12018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-9690LEVALBUTEROL SOLUTION [MYLAN PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 3 package rows20200422_5b4fa89e-aa46-4504-a275-246f3b4df1df.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevalbuterolLEVALBUTEROL HYDROCHLORIDERedpharm Drug58beb877-b94a-bbe0-e063-6294a90a7fe02026-08-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203653
application number: ANDA203653
LevalbuterolLEVALBUTEROL HYDROCHLORIDERedpharm Drug56cb1f4b-ddf4-0661-e063-6394a90a9c452026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203653
application number: ANDA203653
LevalbuterolLEVALBUTEROL HYDROCHLORIDERitedose Pharmaceuticals, LLCd6998949-e1cb-4c86-a480-c0dfd9cb75b52025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203653
application number: ANDA203653
LevalbuterolLEVALBUTEROL HYDROCHLORIDEBryant Ranch Prepacke7e3d858-6a0d-482c-b71b-de90d3ef31692023-09-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203653
application number: ANDA203653
LevalbuterolLEVALBUTEROL HYDROCHLORIDEBryant Ranch Prepackd4080fc5-50d6-49a9-8a63-7769d201968d2023-09-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203653
application number: ANDA203653
LevalbuterolLEVALBUTEROL HYDROCHLORIDEBryant Ranch Prepack2f416dc8-62aa-4b6b-a745-2c8a72bb763d2023-09-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203653
application number: ANDA203653
LevalbuterolLEVALBUTEROL HYDROCHLORIDEA-S Medication Solutions262c0b8b-8461-4bdf-b272-c829d33fd4512023-02-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203653
application number: ANDA203653
LevalbuterolLEVALBUTEROL HYDROCHLORIDEBurel Pharmaceuticals, LLC737fe40b-798b-4d7f-bec9-7af952018ab52021-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203653
application number: ANDA203653
LevalbuterolLEVALBUTEROLMylan Pharmaceuticals Inc.5b4fa89e-aa46-4504-a275-246f3b4df1df2020-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203653
application number: ANDA203653
ndc (product): 0378-9690
LevalbuterolLEVALBUTEROL HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCe5c8368a-49f9-45cf-9d42-a871f005edb92019-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203653
application number: ANDA203653

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349590levalbuterol HCl 0.31 MG in 3 ML Inhalation SolutionPSN5b4fa89e-aa46-4504-a275-246f3b4df1df4
311286levalbuterol HCl 0.63 MG in 3 ML Inhalation SolutionPSN5b4fa89e-aa46-4504-a275-246f3b4df1df4
242754levalbuterol HCl 1.25 MG in 3 ML Inhalation SolutionPSN5b4fa89e-aa46-4504-a275-246f3b4df1df4
349590levalbuterol 0.103 MG/ML Inhalation SolutionSCD5b4fa89e-aa46-4504-a275-246f3b4df1df4
311286levalbuterol 0.21 MG/ML Inhalation SolutionSCD5b4fa89e-aa46-4504-a275-246f3b4df1df4
242754levalbuterol 0.417 MG/ML Inhalation SolutionSCD5b4fa89e-aa46-4504-a275-246f3b4df1df4
349590levalbuterol 0.31 MG (as levalbuterol HCl 0.36 MG) per 3 ML Inhalation SolutionSY5b4fa89e-aa46-4504-a275-246f3b4df1df4
311286levalbuterol 0.63 MG (as levalbuterol HCl 0.73 MG) per 3 ML Inhalation SolutionSY5b4fa89e-aa46-4504-a275-246f3b4df1df4
242754levalbuterol 1.25 MG (as levalbuterol HCl 1.44 MG) per 3 ML Inhalation SolutionSY5b4fa89e-aa46-4504-a275-246f3b4df1df4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-9690-52003789690521 POUCH in 1 CARTON (0378-9690-52) / 25 AMPULE in 1 POUCH (0378-9690-62) / 3 mL in 1 AMPULE1 pouch2018-07-230000-00-00NoNoCurrent
0378-9690-62003789690623 mL in 1 AMPULE3 mlHistorical