FDA.reportPublic FDA data

Levalbuterol Inhalation Solution

Product NDC
47335-753
11-digit product format
473350753
Labeler code
47335
Product ID
47335-753_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
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVALBUTEROL HYDROCHLORIDE1.25 mg/3mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWDQ1526QJM
Rxcui242754, 311286, 349590

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
47335-753-01Levalbuterol Inhalation Solution5 in 1 POUCHSOLUTION54
47335-753-01Levalbuterol Inhalation Solution5 in 1 CARTONSOLUTION54
47335-753-49Levalbuterol Inhalation Solution2 in 1 CARTONSOLUTION24
47335-753-49Levalbuterol Inhalation Solution12 in 1 POUCHSOLUTION124
47335-753-52Levalbuterol Inhalation Solution5 in 1 POUCHSOLUTION54
47335-753-52Levalbuterol Inhalation Solution6 in 1 CARTONSOLUTION64

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-753LEVALBUTEROL 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
47335-753-01473350753015 POUCH in 1 CARTON (47335-753-01) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE5 pouch2020-07-010000-00-00NoNoCurrent
47335-753-49473350753492 POUCH in 1 CARTON (47335-753-49) / 12 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE2 pouch2018-12-010000-00-00NoNoCurrent
47335-753-52473350753526 POUCH in 1 CARTON (47335-753-52) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE6 pouch2018-12-010000-00-00NoNoCurrent