Home NDC 73289-0072 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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218380-001 ARFORMOTEROL TARTRATE ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION AN 2025-02-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218380-001 AN
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A218380-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION AN 2025-02-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218380-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION AN 2025-02-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218380-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION AN 2025-02-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218380-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION AN 2025-02-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218380-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION AN 2025-02-03 b8a1b40f171c…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218380-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION AN 2025-02-03 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Arformoterol Tartrate Inhalation Solution
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ARFORMOTEROL TARTRATE 15 ug/2mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5P8VJ2I235 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 668956 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 73289-0072-1 Arformoterol Tartrate Inhalation Solution 1 in 1 POUCH SOLUTION 1 2 73289-0072-1 Arformoterol Tartrate Inhalation Solution 2 mL in 1 VIAL, SINGLE-DOSE SOLUTION 2 2 73289-0072-2 Arformoterol Tartrate Inhalation Solution 2 mL in 1 VIAL, SINGLE-DOSE SOLUTION 2 2 73289-0072-2 Arformoterol Tartrate Inhalation Solution 4 in 1 POUCH SOLUTION 4 2 73289-0072-3 Arformoterol Tartrate Inhalation Solution 30 in 1 CARTON SOLUTION 30 2 73289-0072-4 Arformoterol Tartrate Inhalation Solution 15 in 1 CARTON SOLUTION 15 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73289-0072 ARFORMOTEROL TARTRATE INHALATION SOLUTION (ARFORMOTEROL TARTRATE) SOLUTION [AUCTA PHARMACEUTICALS, INC.] 2 Current NDC, 6 package rows 20250215_8c0d81db-fbf5-405f-9311-d3d78992d9a3.zip
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 73289-0072-1 73289007201 1 in 1 POUCH Historical 73289-0072-2 73289007202 2 mL in 1 VIAL, SINGLE-DOSE 2 ml Historical 73289-0072-3 73289007203 30 POUCH in 1 CARTON (73289-0072-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (73289-0072-1) / 2 mL in 1 VIAL, SINGLE-DOSE 30 pouch 2025-02-11 No No Current 73289-0072-4 73289007204 15 POUCH in 1 CARTON (73289-0072-4) / 4 VIAL, SINGLE-DOSE in 1 POUCH (73289-0072-2) / 2 mL in 1 VIAL, SINGLE-DOSE 15 pouch 2025-02-11 No No Current