Levalbuterol

Product NDC
68071-2340
11-digit product format
680712340
Labeler code
68071
Product ID
68071-2340_ba5fab26-c896-90e1-e053-2a95a90a6437
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levalbuterol
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA207820
Marketing category
ANDA
Marketing start
2020-05-05
Marketing end
0000-00-00
Substance
LEVALBUTEROL HYDROCHLORIDE
Active strength
1 mg/3mL
Pharmacologic classes
Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2340-5Levalbuterol5 in 1 POUCHSOLUTION51
68071-2340-5Levalbuterol5 in 1 CARTONSOLUTION51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2340LEVALBUTEROL SOLUTION [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 2 package rows20210203_ba5fab26-c897-90e1-e053-2a95a90a6437.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242754levalbuterol HCl 1.25 MG in 3 ML Inhalation SolutionPSNba5fab26-c897-90e1-e053-2a95a90a64371
242754levalbuterol 0.417 MG/ML Inhalation SolutionSCDba5fab26-c897-90e1-e053-2a95a90a64371
242754levalbuterol 1.25 MG (as levalbuterol HCl 1.44 MG) per 3 ML Inhalation SolutionSYba5fab26-c897-90e1-e053-2a95a90a64371

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2340-5680712340055 POUCH in 1 CARTON (68071-2340-5) > 5 VIAL, SINGLE-DOSE in 1 POUCH > 3 mL in 1 VIAL, SINGLE-DOSE5 pouch2021-02-020000-00-00NoNoCurrent