levalbuterol inhalation

Product NDC
43598-412
11-digit product format
435980412
Labeler code
43598
Product ID
43598-412_3ec07be3-1e04-66a2-ffee-b4795006fae9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levalbuterol inhalation 0.31mg/3mL
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Dr. Reddy
Application
ANDA078171
Marketing category
ANDA
Marketing start
2014-09-16
Marketing end
0000-00-00
Substance
LEVALBUTEROL
Active strength
0 mg/3mL
Pharmacologic classes
Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-412-25ML - Milliliter43598-412c0db9dc1-cf06-4cdf-b758-7e7b09e14f0512014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LevalbuterolACTIVE INGREDIENTEDN2NBH5SSLEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.31MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.63MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 1.25MG/3ML) SOLUTION [DR. REDDY’S LABORATORIES, INC.]2
LevalbuterolACTIVE MOIETYEDN2NBH5SSLEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.31MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.63MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 1.25MG/3ML) SOLUTION [DR. REDDY’S LABORATORIES, INC.]2
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KLEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.31MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.63MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 1.25MG/3ML) SOLUTION [DR. REDDY’S LABORATORIES, INC.]2
NitrogenINACTIVE INGREDIENTN762921K75LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.31MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.63MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 1.25MG/3ML) SOLUTION [DR. REDDY’S LABORATORIES, INC.]2
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XLEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.31MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.63MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 1.25MG/3ML) SOLUTION [DR. REDDY’S LABORATORIES, INC.]2
Sulfuric AcidINACTIVE INGREDIENTO40UQP6WCFLEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.31MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.63MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 1.25MG/3ML) SOLUTION [DR. REDDY’S LABORATORIES, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RLEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.31MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.63MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 1.25MG/3ML) SOLUTION [DR. REDDY’S LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-412LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.31MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.63MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 1.25MG/3ML) SOLUTION [DR. REDDY’S LABORATORIES, INC.]4Legacy NDC20241222_163dfa7c-aad3-4290-9fe9-d9592b0ba317.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-412-25435980412255 POUCH in 1 CARTON (43598-412-25) > 5 VIAL in 1 POUCH (43598-412-05) > 3 mL in 1 VIAL5 pouch2014-09-160000-00-00NoNoCurrent