FDA.reportPublic FDA data

Levalbuterol

Product NDC
81894-103
11-digit product format
818940103
Labeler code
81894
Product ID
81894-103_29ead193-b33d-7f78-e063-6294a90a7ef4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levalbuterol
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Luoxin Aurovitas Pharma (Chengdu) Co., Ltd.
Application
ANDA207625
Marketing category
ANDA
Marketing start
2016-12-30
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
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
81894-103-05Levalbuterol5 in 1 POUCHSOLUTION51
81894-103-05Levalbuterol3 mL in 1 VIAL, SINGLE-DOSESOLUTION31
81894-103-25Levalbuterol5 in 1 CARTONSOLUTION51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81894-103LEVALBUTEROL SOLUTION [LUOXIN AUROVITAS PHARMA (CHENGDU) CO., LTD.]1Current NDC, 3 package rows20241226_29eae75d-93da-7a5a-e063-6394a90ac0c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349590levalbuterol HCl 0.31 MG in 3 ML Inhalation SolutionPSN29eae75d-93da-7a5a-e063-6394a90ac0c01
311286levalbuterol HCl 0.63 MG in 3 ML Inhalation SolutionPSN29eae75d-93da-7a5a-e063-6394a90ac0c01
242754levalbuterol HCl 1.25 MG in 3 ML Inhalation SolutionPSN29eae75d-93da-7a5a-e063-6394a90ac0c01
349590levalbuterol 0.103 MG/ML Inhalation SolutionSCD29eae75d-93da-7a5a-e063-6394a90ac0c01
311286levalbuterol 0.21 MG/ML Inhalation SolutionSCD29eae75d-93da-7a5a-e063-6394a90ac0c01
242754levalbuterol 0.417 MG/ML Inhalation SolutionSCD29eae75d-93da-7a5a-e063-6394a90ac0c01
349590levalbuterol 0.31 MG (as levalbuterol HCl 0.36 MG) per 3 ML Inhalation SolutionSY29eae75d-93da-7a5a-e063-6394a90ac0c01
311286levalbuterol 0.63 MG (as levalbuterol HCl 0.73 MG) per 3 ML Inhalation SolutionSY29eae75d-93da-7a5a-e063-6394a90ac0c01
242754levalbuterol 1.25 MG (as levalbuterol HCl 1.44 MG) per 3 ML Inhalation SolutionSY29eae75d-93da-7a5a-e063-6394a90ac0c01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81894-103-05818940103055 in 1 POUCHHistorical
81894-103-25818940103255 POUCH in 1 CARTON (81894-103-25) / 5 VIAL, SINGLE-DOSE in 1 POUCH (81894-103-05) / 3 mL in 1 VIAL, SINGLE-DOSE5 pouch2016-12-30NoNoHistorical