FDA.reportPublic FDA data

Formoterol fumarate

Product NDC
0904-7454
11-digit product format
009047454
Labeler code
0904
Product ID
0904-7454_9aded1f3-a8e1-499c-84d2-e6d12c5d6322
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Formoterol fumarate dihydrate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Major Pharmaceuticals
Application
ANDA215883
Marketing category
ANDA
Marketing start
2024-11-11
Marketing end
2026-07-31
Substance
FORMOTEROL FUMARATE
Active strength
20 ug/2mL
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0904-7454DDiscontinued by firm2026-08-11
excluded packagepackage0904-74540904-7454-11DDiscontinued by firm2026-08-11
excluded packagepackage0904-74540904-7454-14DDiscontinued by firm2026-08-11

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215883-001FORMOTEROL FUMARATEFORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A215883-001AN

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-228072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-22053a50430f4f…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A215883-001AN1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215883-001AN131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215883-001AN16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215883-001AN1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215883-001AN1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215883-001AN103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215883-001AN12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215883-001AN15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215883-001AN1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215883-001AN1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215883-001AN179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215883-001AN1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215883-001AN11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215883-001AN18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215883-001AN16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215883-001AN11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215883-001AN1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215883-001AN1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215883-001AN19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A215883-001AN1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A215883-001AN13f0d92c62455…
2023-05-13 08:27 UTC2023-05A215883-001AN1053a50430f4f…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215883-001AN1a50c72e98297…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0c06c4f4-ea2d-4e6a-a22a-0cf292716367Product name420250303
9ab9f611-cedd-47ea-a83c-0489c8c04fc6Product name120231006
a03aea00-1d8b-bfad-a82e-f52f68676f63Product name220221216
7d8c8d5a-f174-4e6b-97b1-6fd615c5df9aProduct name120210204
1cbe9071-502b-482d-9c24-839b43446576Product name120200123
58f15a44-d9d2-4d61-a39d-7f0223302a8fProduct name120190702
ce066c73-ca6f-49fc-83d4-d3cf6728e8a1Product name120160616

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-7454-11Formoterol fumarate30 in 1 CARTONSOLUTION303
0904-7454-14Formoterol fumarate60 in 1 CARTONSOLUTION603
0904-7454-55Formoterol fumarate4 in 1 POUCHSOLUTION43
0904-7454-55Formoterol fumarate2 mL in 1 VIALSOLUTION23
0904-7454-98Formoterol fumarate1 in 1 POUCHSOLUTION13
0904-7454-98Formoterol fumarate2 mL in 1 VIALSOLUTION23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7454-11ML - Milliliter0904-7454aedebeb0-8cdd-4084-a8af-4f61343177c912024-11-05
0904-7454-14ML - Milliliter0904-74544fc19c40-42a1-4ec1-adf4-0360e0a73b6412024-11-05
0904-7454-55ML - Milliliter0904-7454849ed4d2-4041-4ab2-beaf-caa367a7a99312024-11-05
0904-7454-98ML - Milliliter0904-7454ae7381b9-ee27-4b43-be4c-89044240cc6912024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7454FORMOTEROL FUMARATE (FORMOTEROL FUMARATE DIHYDRATE) SOLUTION [MAJOR PHARMACEUTICALS]2Current NDC, 6 package rows20241113_c77e5f67-01bc-4704-8120-0e2e3d020482.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Formoterol fumarateFORMOTEROL FUMARATE DIHYDRATENorthStar RxLLC4dbb9620-5731-40d9-8258-2977ecc781c42026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215883
application number: ANDA215883
Formoterol fumarateFORMOTEROL FUMARATE DIHYDRATELifestar Pharma LLC35538d89-a984-4335-acdf-85a893f51eee2026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215883
application number: ANDA215883

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1246319formoterol fumarate 20 MCG in 2 ML Inhalation SolutionPSNc77e5f67-01bc-4704-8120-0e2e3d0204823
1246319formoterol fumarate 0.01 MG/ML Inhalation SolutionSCDc77e5f67-01bc-4704-8120-0e2e3d0204823
1246319formoterol fumarate 20 MCG per 2 ML Inhalation SolutionSYc77e5f67-01bc-4704-8120-0e2e3d0204823
1246319formoterol fumarate 20 MCG/2 ML Inhalation SolutionSYc77e5f67-01bc-4704-8120-0e2e3d0204823

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7454-110090474541130 POUCH in 1 CARTON (0904-7454-11) / 1 VIAL in 1 POUCH (0904-7454-98) / 2 mL in 1 VIAL30 pouch2024-11-112026-07-31NoNoHistorical
0904-7454-140090474541460 POUCH in 1 CARTON (0904-7454-14) / 4 VIAL in 1 POUCH (0904-7454-55) / 2 mL in 1 VIAL60 pouch2024-11-112026-07-31NoNoHistorical
0904-7454-55009047454554 in 1 POUCHHistorical
0904-7454-98009047454981 in 1 POUCHHistorical