Levalbuterol

Product NDC
72162-2082
11-digit product format
721622082
Labeler code
72162
Product ID
72162-2082_308a5c8b-e02d-4660-8dd6-2df0dfd0414b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levalbuterol Hydrochloride
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Bryant Ranch Prepack
Application
ANDA203653
Marketing category
ANDA
Marketing start
2016-03-22
Substance
LEVALBUTEROL HYDROCHLORIDE
Active strength
.63 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 HYDROCHLORIDE.63 mg/3mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWDQ1526QJM
Rxcui311286

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
72162-2082-2Levalbuterol1 in 1 CARTONSOLUTION1100
72162-2082-2Levalbuterol25 in 1 POUCHSOLUTION25100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2082-2ML - Milliliter72162-2082aae6b785-8218-4b0a-8047-d92a641952a612023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2082LEVALBUTEROL (LEVALBUTEROL HYDROCHLORIDE) SOLUTION [BRYANT RANCH PREPACK]100Current NDC, 2 package rows20230916_d4080fc5-50d6-49a9-8a63-7769d201968d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311286levalbuterol HCl 0.63 MG in 3 ML Inhalation SolutionPSNd4080fc5-50d6-49a9-8a63-7769d201968d100
311286levalbuterol 0.21 MG/ML Inhalation SolutionSCDd4080fc5-50d6-49a9-8a63-7769d201968d100
311286levalbuterol 0.63 MG (as levalbuterol HCl 0.73 MG) per 3 ML Inhalation SolutionSYd4080fc5-50d6-49a9-8a63-7769d201968d100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2082-2721622082021 POUCH in 1 CARTON (72162-2082-2) / 25 AMPULE in 1 POUCH / 3 mL in 1 AMPULE1 pouch2023-09-14NoNoHistorical