AirDuo Digihaler

Product NDC
59310-111
11-digit product format
593100111
Labeler code
59310
Product ID
59310-111_d4ba573d-49f5-444d-8b91-11764ea3de8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluticasone Propionate and Salmeterol
Dosage form
POWDER, METERED
Route
RESPIRATORY (INHALATION)
Labeler
Teva Respiratory, LLC
Application
NDA208799
Marketing category
NDA
Marketing start
2020-09-15
Marketing end
0000-00-00
Substance
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Active strength
55 ug/1; ug/1
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], 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
59310-111-06EA - Each59310-1112cb5f572-4cf0-4884-9023-4df6c63b90f812020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59310-111AIRDUO DIGIHALER (FLUTICASONE PROPIONATE AND SALMETEROL) POWDER, METERED [TEVA RESPIRATORY, LLC]13Legacy NDC20240430_ac79cc13-4241-427c-a69b-6b00dafcef00.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59310-111-06593100111061 POUCH in 1 CARTON (59310-111-06) > 1 INHALER in 1 POUCH > 1 POWDER, METERED in 1 INHALER1 pouch2020-09-150000-00-00NoNoCurrent