FDA.reportPublic FDA data

Formoterol fumarate

Product NDC
72603-620
11-digit product format
726030620
Labeler code
72603
Product ID
72603-620_56c96143-8313-4b0f-a070-64a0a9b72e08
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Formoterol fumarate dihydrate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
NorthStar RxLLC
Application
ANDA215883
Marketing category
ANDA
Marketing start
2024-07-01
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
2027-12-31
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
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…

Additional Listing Data#

Finished product
Yes
Brand name base
Formoterol fumarate
Listing expiration
2027-12-31

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
4dbb9620-5731-40d9-8258-2977ecc781c4Available 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
72603-620-01Formoterol fumarate2 mL in 1 VIALSOLUTION22
72603-620-01Formoterol fumarate1 in 1 POUCHSOLUTION12
72603-620-04Formoterol fumarate4 in 1 POUCHSOLUTION42
72603-620-04Formoterol fumarate2 mL in 1 VIALSOLUTION22
72603-620-30Formoterol fumarate30 in 1 CARTONSOLUTION302
72603-620-60Formoterol fumarate60 in 1 CARTONSOLUTION602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-620-01ML - Milliliter72603-620572b58d9-1f59-410d-b58f-5531e79a55bf12024-08-12
72603-620-04ML - Milliliter72603-6209205e817-1dea-473f-b818-136c9df2d57212024-08-12
72603-620-30ML - Milliliter72603-620794f7eee-01f0-4d5f-a638-3d8e8096b95b12024-08-12
72603-620-60ML - Milliliter72603-6205491b874-747e-4168-a0e5-b480cda1d3a212024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-620FORMOTEROL FUMARATE (FORMOTEROL FUMARATE DIHYDRATE) SOLUTION [NORTHSTAR RXLLC]1Current NDC, 6 package rows20240701_4dbb9620-5731-40d9-8258-2977ecc781c4.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
ndc (product): 72603-620
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 SolutionPSN4dbb9620-5731-40d9-8258-2977ecc781c42
1246319formoterol fumarate 0.01 MG/ML Inhalation SolutionSCD4dbb9620-5731-40d9-8258-2977ecc781c42
1246319formoterol fumarate 20 MCG per 2 ML Inhalation SolutionSY4dbb9620-5731-40d9-8258-2977ecc781c42
1246319formoterol fumarate 20 MCG/2 ML Inhalation SolutionSY4dbb9620-5731-40d9-8258-2977ecc781c42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-620-01726030620012 mL in 1 VIAL2 mlHistorical
72603-620-04726030620044 in 1 POUCHHistorical
72603-620-307260306203030 POUCH in 1 CARTON (72603-620-30) / 1 VIAL in 1 POUCH (72603-620-01) / 2 mL in 1 VIAL30 pouch2024-07-01NoNoCurrent
72603-620-607260306206060 POUCH in 1 CARTON (72603-620-60) / 4 VIAL in 1 POUCH (72603-620-04) / 2 mL in 1 VIAL60 pouch2024-07-01NoNoCurrent