FDA.reportPublic FDA data

Levalbuterol

Product NDC
0378-9692
11-digit product format
003789692
Labeler code
0378
Product ID
0378-9692_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
2018-09-10
Substance
LEVALBUTEROL HYDROCHLORIDE
Active strength
1.25 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 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
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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A203653-001LEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATIONAN2016-03-22a50c72e98297…
2026-08-01 22:54:322026-06A203653-002LEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATIONAN2016-03-22a50c72e98297…
2026-08-01 22:54:322026-06A203653-003LEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATIONAN2016-03-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A203653-001AN1a50c72e98297…
2026-08-01 22:54:322026-06A203653-002AN1a50c72e98297…
2026-08-01 22:54:322026-06A203653-003AN1a50c72e98297…

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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): 0378-9692
LevalbuterolLEVALBUTEROL HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCe5c8368a-49f9-45cf-9d42-a871f005edb92019-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203653
application number: ANDA203653

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVALBUTEROL HYDROCHLORIDE1.25 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
0378-9692-52Levalbuterol1 in 1 CARTONSOLUTION14
0378-9692-62Levalbuterol3 mL in 1 AMPULESOLUTION34
0378-9692-62Levalbuterol25 in 1 POUCHSOLUTION254

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-9692-52ML - Milliliter0378-9692cc9fd9a8-c416-42de-afcb-5bb93152e31712018-10-11
0378-9692-62ML - Milliliter0378-9692b29205f5-5ef0-4707-a40d-37b5e2261b2212018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-9692LEVALBUTEROL SOLUTION [MYLAN PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 3 package rows20200422_5b4fa89e-aa46-4504-a275-246f3b4df1df.zip

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
0378-9692-52003789692521 POUCH in 1 CARTON (0378-9692-52) / 25 AMPULE in 1 POUCH (0378-9692-62) / 3 mL in 1 AMPULE1 pouch2018-09-100000-00-00NoNoCurrent
0378-9692-62003789692623 mL in 1 AMPULE3 mlHistorical