Home NDC 73289-0060 Formoterol Fumarate
Product NDC 73289-0060
11-digit product format 732890060
Labeler code 73289
Product ID 73289-0060_f1da053e-9d8f-68ee-e053-2995a90a9882
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name formoterol fumarate dihydrate
Dosage form SOLUTION
Route RESPIRATORY (INHALATION)
Labeler Aucta Pharmaceuticals, Inc
Application ANDA216486
Marketing category ANDA
Marketing start 2022-12-15
Marketing end 0000-00-00
Substance FORMOTEROL FUMARATE
Active strength 0 mg/2mL
Pharmacologic classes Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2024-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 73289-0060-2 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 73289-0060-1 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 73289-0060-2 f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 73289-0060-1 f5e01cc5f278…a2eaf40c39c3…
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 A216486-001 FORMOTEROL FUMARATE FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2022-11-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216486-001 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 A216486-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2022-11-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216486-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2022-11-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216486-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2022-11-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216486-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2022-11-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216486-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2022-11-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216486-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2022-11-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216486-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2022-11-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216486-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2022-11-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216486-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2022-11-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216486-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2022-11-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216486-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2022-11-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216486-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2022-11-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216486-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2022-11-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216486-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2022-11-25 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216486-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2022-11-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216486-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2022-11-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216486-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2022-11-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216486-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2022-11-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216486-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2022-11-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216486-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2022-11-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216486-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2022-11-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216486-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2022-11-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A216486-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2022-11-25 3bdfa0b2c4d7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216486-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2022-11-25 a50c72e98297…
Observed Orange Book normalized TE history# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 73289-0060-1 73289006001 30 POUCH in 1 CARTON (73289-0060-1) > 2 mL in 1 POUCH (73289-0060-3) 30 pouch 2022-12-15 0000-00-00 No No Current 73289-0060-2 73289006002 60 POUCH in 1 CARTON (73289-0060-2) > 2 mL in 1 POUCH (73289-0060-3) 60 pouch 2022-12-15 0000-00-00 No No Current