FDA.reportPublic FDA data

DUAKLIR PRESSAIR

Product NDC
70515-001
11-digit product format
705150001
Labeler code
70515
Product ID
70515-001_2eba3089-28b4-4190-9fba-2511246cfd16
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
aclidinium bromide and formoterol fumarate
Dosage form
POWDER, METERED
Route
RESPIRATORY (INHALATION)
Labeler
Covis Pharma US, Inc
Application
NDA210595
Marketing category
NDA
Marketing start
2019-03-29
Substance
ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE
Active strength
400; 12 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DUAKLIR PRESSAIR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACLIDINIUM BROMIDE400 ug/1
FORMOTEROL FUMARATE12 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUQW7UF9N91, W34SHF8J2K
Rxcui2205094, 2205099, 2205103, 2205104

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0c06c4f4-ea2d-4e6a-a22a-0cf292716367Product name420250303
9ab9f611-cedd-47ea-a83c-0489c8c04fc6Product name120231006
a03aea00-1d8b-bfad-a82e-f52f68676f63Product name220221216
7d8c8d5a-f174-4e6b-97b1-6fd615c5df9aProduct name120210204
1cbe9071-502b-482d-9c24-839b43446576Product name120200123
58f15a44-d9d2-4d61-a39d-7f0223302a8fProduct name120190702
ce066c73-ca6f-49fc-83d4-d3cf6728e8a1Product name120160616

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70515-001-01DUAKLIR PRESSAIR1 in 1 CARTONPOWDER, METERED11
70515-001-01DUAKLIR PRESSAIR1 in 1 POUCHPOWDER, METERED11
70515-001-03DUAKLIR PRESSAIR1 in 1 CARTONPOWDER, METERED11
70515-001-03DUAKLIR PRESSAIR1 in 1 POUCHPOWDER, METERED11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70515-001-01EA - Each70515-0010cc3d7e7-dfdd-45a9-a831-fe1f884dbac412024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70515-001DUAKLIR PRESSAIR (ACLIDINIUM BROMIDE AND FORMOTEROL FUMARATE) POWDER, METERED [COVIS PHARMA US, INC]1Current NDC, 4 package rows20231208_2eba3089-28b4-4190-9fba-2511246cfd16.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2205103aclidinium bromide 400 MCG/ACTUAT / formoterol fumarate 12 MCG/ACTUAT Dry Powder Inhaler, 30 ActuationsPSN2eba3089-28b4-4190-9fba-2511246cfd161
2205094aclidinium bromide 400 MCG/ACTUAT / formoterol fumarate 12 MCG/ACTUAT Dry Powder Inhaler, 60 ActuationsPSN2eba3089-28b4-4190-9fba-2511246cfd161
2205104Duaklir Pressair 400/12 MCG/INHAL Dry Powder Inhaler, 30 ActuationsPSN2eba3089-28b4-4190-9fba-2511246cfd161
2205099Duaklir Pressair 400/12 MCG/INHAL Dry Powder Inhaler, 60 ActuationsPSN2eba3089-28b4-4190-9fba-2511246cfd161
220510430 ACTUAT aclidinium bromide 0.4 MG/ACTUAT / formoterol fumarate 0.012 MG/ACTUAT Dry Powder Inhaler [Duaklir]SBD2eba3089-28b4-4190-9fba-2511246cfd161
220509960 ACTUAT aclidinium bromide 0.4 MG/ACTUAT / formoterol fumarate 0.012 MG/ACTUAT Dry Powder Inhaler [Duaklir]SBD2eba3089-28b4-4190-9fba-2511246cfd161
220510330 ACTUAT aclidinium bromide 0.4 MG/ACTUAT / formoterol fumarate 0.012 MG/ACTUAT Dry Powder InhalerSCD2eba3089-28b4-4190-9fba-2511246cfd161
220509460 ACTUAT aclidinium bromide 0.4 MG/ACTUAT / formoterol fumarate 0.012 MG/ACTUAT Dry Powder InhalerSCD2eba3089-28b4-4190-9fba-2511246cfd161
2205104Duaklir Pressair 400/12 ( aclidinium bromide 400 MCG/ formoterol fumarate 12 MCG ) per ACTUAT Dry Powder Inhaler, 30 ActuationsSY2eba3089-28b4-4190-9fba-2511246cfd161
2205099Duaklir Pressair 400/12 ( aclidinium bromide 400 MCG/ formoterol fumarate 12 MCG ) per ACTUAT Dry Powder Inhaler, 60 ActuationsSY2eba3089-28b4-4190-9fba-2511246cfd161

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70515-001-01705150001011 POUCH in 1 CARTON (70515-001-01) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER1 pouch2019-03-29NoNoCurrent
70515-001-03705150001031 POUCH in 1 CARTON (70515-001-03) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER1 pouch2019-03-29NoNoCurrent