FDA.reportPublic FDA data

Levalbuterol Inhalation Solution

Product NDC
47335-743
11-digit product format
473350743
Labeler code
47335
Product ID
47335-743_f264b091-1414-4e44-abae-d0b787c94397
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levalbuterol Inhalation Solution
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA207820
Marketing category
ANDA
Marketing start
2018-12-01
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 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
A207820-001LEVALBUTEROL HYDROCHLORIDELEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATION2018-11-05
A207820-002LEVALBUTEROL HYDROCHLORIDELEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATION2018-11-05
A207820-003LEVALBUTEROL HYDROCHLORIDELEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATION2018-11-05

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 22:54:322026-06A207820-001LEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATION2018-11-05a50c72e98297…
2026-08-01 22:54:322026-06A207820-002LEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATION2018-11-05a50c72e98297…
2026-08-01 22:54:322026-06A207820-003LEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATION2018-11-05a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levalbuterol Inhalation SolutionLEVALBUTEROL INHALATION SOLUTIONSun Pharmaceutical Industries, Inc.85a59e0c-ff09-49a6-b7b8-616e033107b42020-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207820
application number: ANDA207820
ndc (product): 47335-743

Additional Listing Data#

Finished product
Yes
Brand name base
Levalbuterol Inhalation Solution
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
85a59e0c-ff09-49a6-b7b8-616e033107b4Available 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
47335-743-01Levalbuterol Inhalation Solution5 in 1 POUCHSOLUTION54
47335-743-01Levalbuterol Inhalation Solution5 in 1 CARTONSOLUTION54
47335-743-49Levalbuterol Inhalation Solution2 in 1 CARTONSOLUTION24
47335-743-49Levalbuterol Inhalation Solution12 in 1 POUCHSOLUTION124
47335-743-52Levalbuterol Inhalation Solution6 in 1 CARTONSOLUTION64
47335-743-52Levalbuterol Inhalation Solution5 in 1 POUCHSOLUTION54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-743LEVALBUTEROL INHALATION SOLUTION SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]4Current NDC, Legacy NDC, 6 package rows20200501_85a59e0c-ff09-49a6-b7b8-616e033107b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349590levalbuterol HCl 0.31 MG in 3 ML Inhalation SolutionPSN85a59e0c-ff09-49a6-b7b8-616e033107b44
311286levalbuterol HCl 0.63 MG in 3 ML Inhalation SolutionPSN85a59e0c-ff09-49a6-b7b8-616e033107b44
242754levalbuterol HCl 1.25 MG in 3 ML Inhalation SolutionPSN85a59e0c-ff09-49a6-b7b8-616e033107b44
349590levalbuterol 0.103 MG/ML Inhalation SolutionSCD85a59e0c-ff09-49a6-b7b8-616e033107b44
311286levalbuterol 0.21 MG/ML Inhalation SolutionSCD85a59e0c-ff09-49a6-b7b8-616e033107b44
242754levalbuterol 0.417 MG/ML Inhalation SolutionSCD85a59e0c-ff09-49a6-b7b8-616e033107b44
349590levalbuterol 0.31 MG (as levalbuterol HCl 0.36 MG) per 3 ML Inhalation SolutionSY85a59e0c-ff09-49a6-b7b8-616e033107b44
311286levalbuterol 0.63 MG (as levalbuterol HCl 0.73 MG) per 3 ML Inhalation SolutionSY85a59e0c-ff09-49a6-b7b8-616e033107b44
242754levalbuterol 1.25 MG (as levalbuterol HCl 1.44 MG) per 3 ML Inhalation SolutionSY85a59e0c-ff09-49a6-b7b8-616e033107b44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47335-743-01473350743015 POUCH in 1 CARTON (47335-743-01) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE5 pouch2020-07-010000-00-00NoNoCurrent
47335-743-49473350743492 POUCH in 1 CARTON (47335-743-49) / 12 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE2 pouch2018-12-010000-00-00NoNoCurrent
47335-743-52473350743526 POUCH in 1 CARTON (47335-743-52) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE6 pouch2018-12-010000-00-00NoNoCurrent