Tudorza Pressair

Product NDC
72124-002
11-digit product format
721240002
Labeler code
72124
Product ID
72124-002_e5e42a8e-0d34-47a3-b337-552193a224a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
aclidinium bromide
Dosage form
POWDER, METERED
Route
RESPIRATORY (INHALATION)
Labeler
Circassia Pharmaceuticals Inc.
Application
NDA202450
Marketing category
NDA
Marketing start
2019-07-01
Marketing end
2023-08-31
Substance
ACLIDINIUM BROMIDE
Active strength
400 ug/1
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72124-002-01EA - Each72124-002c8025980-3fc7-4654-918a-adb0fb19bb5a12019-08-06
72124-002-02EA - Each72124-00230c3baa6-c727-4947-98af-5df0b6ff77b012019-06-19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72124-002-01721240002011 POUCH in 1 CARTON (72124-002-01) > 1 INHALER in 1 POUCH > 60 POWDER, METERED in 1 INHALER1 pouch2019-07-012023-08-31NoNoCurrent
72124-002-02721240002021 POUCH in 1 CARTON (72124-002-02) > 1 INHALER in 1 POUCH > 30 POWDER, METERED in 1 INHALER1 pouch2019-07-012022-09-30NoNoCurrent
72124-002-03721240002031 POUCH in 1 CARTON (72124-002-03) > 1 INHALER in 1 POUCH > 30 POWDER, METERED in 1 INHALER1 pouch2019-07-012022-11-30YesNoCurrent