Levalbuterol tartrate HFA inhalation

Product NDC
63629-8822
11-digit product format
636298822
Labeler code
63629
Product ID
63629-8822_22ccefa8-e011-4165-a8cb-7cfca73f21b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levalbuterol tartrate
Dosage form
AEROSOL, METERED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA021730
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2016-10-03
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8822-1GM - Gram63629-8822ec946695-d1eb-4e38-9b72-6a4324898c9f12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8822LEVALBUTEROL TARTRATE HFA INHALATION (LEVALBUTEROL TARTRATE) AEROSOL, METERED [BRYANT RANCH PREPACK]102Legacy NDC20240116_bf8063b2-85cc-4a7f-a106-af277499154c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8822-1636298822011 INHALER in 1 CARTON (63629-8822-1) > 200 AEROSOL, METERED in 1 INHALER1 inhaler2021-09-150000-00-00NoNoCurrent