Home NDC 50742-394 Formoterol Fumarate
Product NDC 50742-394
11-digit product format 507420394
Labeler code 50742
Product ID 50742-394_36df181b-7f3a-3ad2-e063-6294a90ab756
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Formoterol Fumarate
Dosage form SOLUTION
Route RESPIRATORY (INHALATION)
Labeler Ingenus Pharmaceuticals, LLC
Application ANDA216426
Marketing category ANDA
Marketing start 2025-06-05
Substance FORMOTEROL FUMARATE
Active strength .02 mg/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 A216426-001 FORMOTEROL FUMARATE FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2024-10-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216426-001 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 A216426-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2024-10-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216426-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2024-10-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216426-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2024-10-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216426-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2024-10-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216426-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2024-10-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216426-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2024-10-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216426-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2024-10-22 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216426-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2024-10-22 d8e5a09893c0…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216426-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2024-10-22 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Formoterol Fumarate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FORMOTEROL FUMARATE .02 mg/2mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination W34SHF8J2K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1246319 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 50742-394-01 Formoterol Fumarate 1 in 1 POUCH SOLUTION 1 4 50742-394-01 Formoterol Fumarate 2 mL in 1 VIAL, SINGLE-DOSE SOLUTION 2 4 50742-394-30 Formoterol Fumarate 30 in 1 CARTON SOLUTION 30 4 50742-394-60 Formoterol Fumarate 1 in 1 POUCH SOLUTION 1 4 50742-394-60 Formoterol Fumarate 60 in 1 CARTON SOLUTION 60 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50742-394 FORMOTEROL FUMARATE SOLUTION [INGENUS PHARMACEUTICALS, LLC] 3 Current NDC, 5 package rows 20250317_303479a7-80fb-1f6d-e063-6394a90abbda.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 50742-394-01 50742039401 1 in 1 POUCH Historical 50742-394-30 50742039430 30 POUCH in 1 CARTON (50742-394-30) / 1 VIAL, SINGLE-DOSE in 1 POUCH (50742-394-01) / 2 mL in 1 VIAL, SINGLE-DOSE 30 pouch 2025-06-06 No No Current 50742-394-60 50742039460 60 POUCH in 1 CARTON (50742-394-60) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE 60 pouch 2025-06-05 No No Current