Tudorza Pressair

Product NDC
0310-0800
11-digit product format
003100800
Labeler code
0310
Product ID
0310-0800_4e3ae998-ea80-4478-9ba1-ab36d05e1cc4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
aclidinium bromide
Dosage form
POWDER, METERED
Route
RESPIRATORY (INHALATION)
Labeler
AstraZeneca Pharmaceuticals LP
Application
NDA202450
Marketing category
NDA
Marketing start
2015-07-01
Marketing end
2024-07-31
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
0310-0800-39EA - Each0310-08005e52b7e7-4a7b-46ba-825c-c715877dd44e12015-07-20
0310-0800-60EA - Each0310-0800c9125009-cdad-4ff1-8937-4094bcc17cbb12015-07-20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0310-0800-39003100800391 POUCH in 1 CARTON (0310-0800-39) > 1 INHALER in 1 POUCH > 30 POWDER, METERED in 1 INHALER1 pouch2015-07-010000-00-00NoNoCurrent
0310-0800-60003100800601 POUCH in 1 CARTON (0310-0800-60) > 1 INHALER in 1 POUCH > 60 POWDER, METERED in 1 INHALER1 pouch2015-07-010000-00-00NoNoCurrent
0310-0800-95003100800951 POUCH in 1 CARTON (0310-0800-95) > 1 INHALER in 1 POUCH > 30 POWDER, METERED in 1 INHALER1 pouch2015-07-010000-00-00YesNoCurrent