FDA.reportPublic FDA data

Arformoterol Tartrate Inhalation Solution

Product NDC
73289-0072
11-digit product format
732890072
Labeler code
73289
Product ID
73289-0072_2de3ae20-a1ec-6be3-e063-6294a90af05a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Arformoterol Tartrate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Aucta Pharmaceuticals, Inc.
Application
ANDA218380
Marketing category
ANDA
Marketing start
2025-02-11
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 Solution
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
73289-0072-1Arformoterol Tartrate Inhalation Solution1 in 1 POUCHSOLUTION12
73289-0072-1Arformoterol Tartrate Inhalation Solution2 mL in 1 VIAL, SINGLE-DOSESOLUTION22
73289-0072-2Arformoterol Tartrate Inhalation Solution2 mL in 1 VIAL, SINGLE-DOSESOLUTION22
73289-0072-2Arformoterol Tartrate Inhalation Solution4 in 1 POUCHSOLUTION42
73289-0072-3Arformoterol Tartrate Inhalation Solution30 in 1 CARTONSOLUTION302
73289-0072-4Arformoterol Tartrate Inhalation Solution15 in 1 CARTONSOLUTION152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73289-0072ARFORMOTEROL TARTRATE INHALATION SOLUTION (ARFORMOTEROL TARTRATE) SOLUTION [AUCTA PHARMACEUTICALS, INC.]2Current NDC, 6 package rows20250215_8c0d81db-fbf5-405f-9311-d3d78992d9a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
668956arformoterol tartrate 15 MCG in 2 ML Inhalation SolutionPSN8c0d81db-fbf5-405f-9311-d3d78992d9a32
668956arformoterol 0.0075 MG/ML Inhalation SolutionSCD8c0d81db-fbf5-405f-9311-d3d78992d9a32
668956arformoterol 0.0075 MG/ML (arformoterol tartrate 0.011 MG/ML) Inhalation SolutionSY8c0d81db-fbf5-405f-9311-d3d78992d9a32
668956arformoterol 15 MCG per 2 ML Inhalation SolutionSY8c0d81db-fbf5-405f-9311-d3d78992d9a32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73289-0072-1732890072011 in 1 POUCHHistorical
73289-0072-2732890072022 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
73289-0072-37328900720330 POUCH in 1 CARTON (73289-0072-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (73289-0072-1) / 2 mL in 1 VIAL, SINGLE-DOSE30 pouch2025-02-11NoNoHistorical
73289-0072-47328900720415 POUCH in 1 CARTON (73289-0072-4) / 4 VIAL, SINGLE-DOSE in 1 POUCH (73289-0072-2) / 2 mL in 1 VIAL, SINGLE-DOSE15 pouch2025-02-11NoNoHistorical