FDA.reportPublic FDA data

Formoterol fumarate

Product NDC
73043-051
11-digit product format
730430051
Labeler code
73043
Product ID
73043-051_7f289241-a13a-4a5f-b579-7b15dbab3d44
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Formoterol fumarate dihydrate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Devatis, Inc.
Application
ANDA218308
Marketing category
ANDA
Marketing start
2025-06-30
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218308-001FORMOTEROL FUMARATEFORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2025-02-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218308-001AN

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 UTC2026-02A218308-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2025-02-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218308-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2025-02-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218308-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2025-02-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218308-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2025-02-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218308-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2025-02-11b8a1b40f171c…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218308-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2025-02-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A218308-001AN1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218308-001AN131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218308-001AN16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218308-001AN1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218308-001AN1b8a1b40f171c…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218308-001AN1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Formoterol fumarate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FORMOTEROL FUMARATE20 ug/2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
W34SHF8J2KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1246319Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
fd0dac5d-e58c-46ee-9d28-1a1ef7a6be5eAvailable on FDA.report

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
73043-051-93Formoterol fumarate1 in 1 POUCHSOLUTION11
73043-051-93Formoterol fumarate30 in 1 CARTONSOLUTION301
73043-051-96Formoterol fumarate60 in 1 CARTONSOLUTION601
73043-051-96Formoterol fumarate1 in 1 POUCHSOLUTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73043-051-93ML - Milliliter73043-0519d9604cb-b2f1-461d-bebc-8fe2945eb30012025-11-13
73043-051-96ML - Milliliter73043-0516087b432-9ed5-4391-9f0e-0dea240e14ee12025-11-13

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Formoterol fumarateFORMOTEROL FUMARATE DIHYDRATEDevatis, Inc.fd0dac5d-e58c-46ee-9d28-1a1ef7a6be5e2025-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218308
application number: ANDA218308
ndc (product): 73043-051

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1246319formoterol fumarate 20 MCG in 2 ML Inhalation SolutionPSNfd0dac5d-e58c-46ee-9d28-1a1ef7a6be5e1
1246319formoterol fumarate 0.01 MG/ML Inhalation SolutionSCDfd0dac5d-e58c-46ee-9d28-1a1ef7a6be5e1
1246319formoterol fumarate 20 MCG per 2 ML Inhalation SolutionSYfd0dac5d-e58c-46ee-9d28-1a1ef7a6be5e1
1246319formoterol fumarate 20 MCG/2 ML Inhalation SolutionSYfd0dac5d-e58c-46ee-9d28-1a1ef7a6be5e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73043-051-937304300519330 POUCH in 1 CARTON (73043-051-93) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL30 pouch2025-06-30NoNoCurrent
73043-051-967304300519660 POUCH in 1 CARTON (73043-051-96) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL60 pouch2025-06-30NoNoCurrent