Home NDC 63629-8813 Formoterol fumarate
Product NDC 63629-8813
11-digit product format 636298813
Labeler code 63629
Product ID 63629-8813_37f67ff0-5292-47b4-849e-25cf51d1d61b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Formoterol fumarate
Dosage form SOLUTION
Route RESPIRATORY (INHALATION)
Labeler Bryant Ranch Prepack
Application ANDA091141
Marketing category ANDA
Marketing start 2021-06-22
Substance FORMOTEROL FUMARATE
Active strength 20 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 A091141-001 FORMOTEROL FUMARATE FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2021-06-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091141-001 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 A091141-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2021-06-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091141-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2021-06-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091141-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2021-06-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091141-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2021-06-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091141-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2021-06-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091141-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2021-06-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091141-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2021-06-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091141-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2021-06-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091141-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2021-06-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091141-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2021-06-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091141-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2021-06-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091141-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2021-06-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091141-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2021-06-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091141-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2021-06-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091141-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2021-06-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091141-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2021-06-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091141-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2021-06-22 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A091141-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2021-06-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091141-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2021-06-22 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091141-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2021-06-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091141-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2021-06-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091141-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2021-06-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091141-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2021-06-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091141-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2021-06-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091141-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2021-06-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091141-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2021-06-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091141-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2021-06-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091141-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2021-06-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091141-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2021-06-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091141-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2021-06-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091141-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2021-06-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091141-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2021-06-22 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A091141-001 FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN 2021-06-22 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 20 ug/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 63629-8813-1 Formoterol fumarate 1 in 1 POUCH SOLUTION 1 102 63629-8813-1 Formoterol fumarate 30 in 1 CARTON SOLUTION 30 102
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-8813 FORMOTEROL FUMARATE SOLUTION [BRYANT RANCH PREPACK] 102 Current NDC, Legacy NDC, 2 package rows 20240113_9786f3e2-4265-4246-9999-f73cd6b33fc8.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63629-8813-1 63629881301 30 POUCH in 1 CARTON (63629-8813-1) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL 30 pouch 2021-09-10 0000-00-00 No No Current