FDA.reportPublic FDA data

Arformoterol Tartrate Inhalation

Product NDC
73043-052
11-digit product format
730430052
Labeler code
73043
Product ID
73043-052_8f1bd281-a307-4e2c-8796-6b55495bd3e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Arformoterol Tartrate Inhalation
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Devatis, Inc.
Application
ANDA218429
Marketing category
ANDA
Marketing start
2025-08-01
Substance
ARFORMOTEROL TARTRATE
Active strength
15 ug/2mL
Pharmacologic classes
Adrenergic beta2-Agonists [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
Arformoterol Tartrate Inhalation
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARFORMOTEROL TARTRATE15 ug/2mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5P8VJ2I235
Rxcui668956

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15e9fde8-93fa-6f6d-5bf2-f94be8a41a73Product name620260202

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73043-052-01Arformoterol Tartrate Inhalation2 mL in 1 VIALSOLUTION21
73043-052-01Arformoterol Tartrate Inhalation1 in 1 POUCHSOLUTION11
73043-052-04Arformoterol Tartrate Inhalation4 in 1 POUCHSOLUTION41
73043-052-04Arformoterol Tartrate Inhalation2 mL in 1 VIALSOLUTION21
73043-052-60Arformoterol Tartrate Inhalation60 in 1 CARTONSOLUTION601
73043-052-93Arformoterol Tartrate Inhalation30 in 1 CARTONSOLUTION301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73043-052-01ML - Milliliter73043-052523c567a-86e1-4927-89ab-42c4a00a1cd212025-10-14
73043-052-04ML - Milliliter73043-05262f5b938-c471-4564-ba64-30c6b64ad1c012025-10-14
73043-052-60ML - Milliliter73043-05247817bb4-9f03-4fe6-9cce-83aec806463712025-10-14
73043-052-93ML - Milliliter73043-05288088a8c-c27f-4a24-883d-859f037a0df612025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
668956arformoterol tartrate 15 MCG in 2 ML Inhalation SolutionPSNa4b5c1fd-6dee-4c0a-a7c6-b6baaba2bb991
668956arformoterol 0.0075 MG/ML Inhalation SolutionSCDa4b5c1fd-6dee-4c0a-a7c6-b6baaba2bb991
668956arformoterol 0.0075 MG/ML (arformoterol tartrate 0.011 MG/ML) Inhalation SolutionSYa4b5c1fd-6dee-4c0a-a7c6-b6baaba2bb991
668956arformoterol 15 MCG per 2 ML Inhalation SolutionSYa4b5c1fd-6dee-4c0a-a7c6-b6baaba2bb991

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73043-052-01730430052012 mL in 1 VIAL2 mlHistorical
73043-052-04730430052044 in 1 POUCHHistorical
73043-052-607304300526060 POUCH in 1 CARTON (73043-052-60) / 4 VIAL in 1 POUCH (73043-052-04) / 2 mL in 1 VIAL60 pouch2025-08-01NoNoHistorical
73043-052-937304300529330 POUCH in 1 CARTON (73043-052-93) / 1 VIAL in 1 POUCH (73043-052-01) / 2 mL in 1 VIAL30 pouch2025-08-01NoNoHistorical