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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218429-001ARFORMOTEROL TARTRATEARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2025-04-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A218429-001AN

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A218429-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2025-04-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218429-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2025-04-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A218429-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2025-04-256a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218429-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2025-04-25a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A218429-001AN1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218429-001AN131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218429-001AN16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218429-001AN1a50c72e98297…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5P8VJ2I235Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
668956Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a4b5c1fd-6dee-4c0a-a7c6-b6baaba2bb99Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Arformoterol Tartrate InhalationARFORMOTEROL TARTRATE INHALATIONDevatis, Inc.a4b5c1fd-6dee-4c0a-a7c6-b6baaba2bb992025-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218429
application number: ANDA218429
ndc (product): 73043-052

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 pouch2025-08-01NoNoCurrent
73043-052-937304300529330 POUCH in 1 CARTON (73043-052-93) / 1 VIAL in 1 POUCH (73043-052-01) / 2 mL in 1 VIAL30 pouch2025-08-01NoNoCurrent