Home NDC 0378-1631 FORMOTEROL FUMARATE
Product NDC 0378-1631
11-digit product format 003781631
Labeler code 0378
Product ID 0378-1631_db19667d-88cd-47ab-adb5-894959822801
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name formoterol fumarate dihydrate
Dosage form SOLUTION
Route RESPIRATORY (INHALATION)
Labeler Mylan Pharmaceuticals Inc.
Application NDA022007
Marketing category NDA AUTHORIZED GENERIC
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 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 2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0378-1631-91 ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0378-1631-93 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0378-1631-91 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0378-1631-93 0efc9e666f02…f202fb6c5f17…
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 N022007-001 PERFOROMIST FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION / INHALATION AN RLD, RS 2007-05-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022007-001 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.
Product history page 1 of 2 · 41 observed 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 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION AN RLD, RS 2007-05-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION AN RLD, RS 2007-05-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION AN RLD, RS 2007-05-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION AN RLD, RS 2007-05-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION AN RLD, RS 2007-05-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION AN RLD, RS 2007-05-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION AN RLD, RS 2007-05-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION AN RLD, RS 2007-05-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION AN RLD, RS 2007-05-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION AN RLD, RS 2007-05-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION AN RLD, RS 2007-05-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION AN RLD, RS 2007-05-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION AN RLD, RS 2007-05-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION AN RLD, RS 2007-05-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION AN RLD, RS 2007-05-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION AN RLD, RS 2007-05-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION AN RLD, RS 2007-05-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION RLD, RS 2007-05-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION AN RLD, RS 2007-05-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION AN RLD, RS 2007-05-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION RLD, RS 2007-05-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION RLD, RS 2007-05-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION RLD, RS 2007-05-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION RLD, RS 2007-05-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION RLD, RS 2007-05-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION RLD, RS 2007-05-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION RLD, RS 2007-05-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION AN RLD, RS 2007-05-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION AN RLD, RS 2007-05-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION AN RLD, RS 2007-05-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION AN RLD, RS 2007-05-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION AN RLD, RS 2007-05-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION AN RLD, RS 2007-05-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION AN RLD, RS 2007-05-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION AN RLD, RS 2007-05-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION AN RLD, RS 2007-05-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION AN RLD, RS 2007-05-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION AN RLD, RS 2007-05-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION AN RLD, RS 2007-05-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022007-001 PERFOROMIST 0.02MG/2ML SOLUTION / INHALATION AN RLD, RS 2007-05-11 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 2 · 54 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N022007-001 6667344 2021-06-22 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022007-001 6814953 2021-06-22 U-813 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022007-001 7348362 2021-06-22 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022007-001 7462645 2021-06-22 U-813 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022007-001 8623922 2021-06-22 Drug product 2014-05-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022007-001 9730890 2021-06-22 Drug product 2018-01-23 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 N022007-001 6667344 2021-06-22 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022007-001 6814953 2021-06-22 U-813 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022007-001 7348362 2021-06-22 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022007-001 7462645 2021-06-22 U-813 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022007-001 8623922 2021-06-22 Drug product 2014-05-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022007-001 9730890 2021-06-22 Drug product 2018-01-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022007-001 6667344 2021-06-22 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022007-001 6814953 2021-06-22 U-813 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022007-001 7348362 2021-06-22 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022007-001 7462645 2021-06-22 U-813 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022007-001 8623922 2021-06-22 Drug product 2014-05-30 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022007-001 9730890 2021-06-22 Drug product 2018-01-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022007-001 6667344 2021-06-22 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N022007-001 6814953 2021-06-22 U-813 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N022007-001 7348362 2021-06-22 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N022007-001 7462645 2021-06-22 U-813 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N022007-001 8623922 2021-06-22 Drug product 2014-05-30 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N022007-001 9730890 2021-06-22 Drug product 2018-01-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022007-001 6667344 2021-06-22 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022007-001 6814953 2021-06-22 U-813 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022007-001 7348362 2021-06-22 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022007-001 7462645 2021-06-22 U-813 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022007-001 8623922 2021-06-22 Drug product 2014-05-30 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022007-001 9730890 2021-06-22 Drug product 2018-01-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022007-001 6667344 2021-06-22 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N022007-001 6814953 2021-06-22 U-813 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N022007-001 7348362 2021-06-22 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N022007-001 7462645 2021-06-22 U-813 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N022007-001 8623922 2021-06-22 Drug product 2014-05-30 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N022007-001 9730890 2021-06-22 Drug product 2018-01-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022007-001 6667344 2021-06-22 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022007-001 6814953 2021-06-22 U-813 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022007-001 7348362 2021-06-22 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022007-001 7462645 2021-06-22 U-813 Drug product 3f01610625f2…
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 0378-1631-32 FORMOTEROL FUMARATE 2 mL in 1 VIAL SOLUTION 2 5 0378-1631-32 FORMOTEROL FUMARATE 1 in 1 POUCH SOLUTION 1 5 0378-1631-91 FORMOTEROL FUMARATE 60 in 1 CARTON SOLUTION 60 5 0378-1631-91 FORMOTEROL FUMARATE 1 in 1 POUCH SOLUTION 1 5 0378-1631-93 FORMOTEROL FUMARATE 30 in 1 CARTON SOLUTION 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-1631 FORMOTEROL FUMARATE (FORMOTEROL FUMARATE DIHYDRATE) SOLUTION [MYLAN PHARMACEUTICALS INC.] 5 Current NDC, Legacy NDC, 5 package rows 20250123_6c1a6c53-af85-4220-9ce3-2373e0928f7f.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 · 2 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 0378-1631-32 00378163132 2 mL in 1 VIAL 2 ml Historical 0378-1631-91 00378163191 60 POUCH in 1 CARTON (0378-1631-91) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL 60 pouch 2021-06-22 0000-00-00 No No Current 0378-1631-93 00378163193 30 POUCH in 1 CARTON (0378-1631-93) / 1 VIAL in 1 POUCH (0378-1631-32) / 2 mL in 1 VIAL 30 pouch 2021-06-22 0000-00-00 No No Current