Levalbuterol tartrate HFA inhalation

Product NDC
59368-410
11-digit product format
593680410
Labeler code
59368
Product ID
59368-410_37c9bb3a-2206-194d-e063-6394a90a145c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levalbuterol tartrate
Dosage form
AEROSOL, METERED
Route
ORAL
Labeler
Praxis, LLC
Application
NDA021730
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2016-10-03
Substance
LEVALBUTEROL TARTRATE
Active strength
45 ug/1
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
59368-410-01Levalbuterol tartrate HFA inhalation1 in 1 CARTONAEROSOL, METERED11
59368-410-01Levalbuterol tartrate HFA inhalation200 in 1 INHALERAEROSOL, METERED2001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59368-410-01593680410011 INHALER in 1 CARTON (59368-410-01) / 200 AEROSOL, METERED in 1 INHALER1 inhaler2016-10-03NoNoHistorical