DUAKLIR PRESSAIR

Product NDC
0310-0900
11-digit product format
003100900
Labeler code
0310
Product ID
0310-0900_8a53bfe1-e02e-46c3-a8b4-54f89d4897c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
aclidinium bromide and formoterol fumarate
Dosage form
POWDER, METERED
Route
RESPIRATORY (INHALATION)
Labeler
AstraZeneca Pharmaceuticals LP
Application
NDA210595
Marketing category
NDA
Marketing start
2022-08-17
Marketing end
2025-04-30
Substance
ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE
Active strength
400 ug/1; ug/1
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]
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
0310-0900-60EA - Each0310-090016a4e00a-160f-44db-b8a5-5e4abe3df1a212022-10-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0310-0900-30003100900301 POUCH in 1 CARTON (0310-0900-30) > 1 INHALER in 1 POUCH > 30 POWDER, METERED in 1 INHALER1 pouch2022-08-172024-09-30NoNoCurrent
0310-0900-60003100900601 POUCH in 1 CARTON (0310-0900-60) > 1 INHALER in 1 POUCH > 60 POWDER, METERED in 1 INHALER1 pouch2022-08-172025-04-30NoNoCurrent