Arformoterol tartrate

Product NDC
72266-259
11-digit product format
722660259
Labeler code
72266
Product ID
72266-259_2aba8bac-6807-dca1-e063-6394a90a01f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Arformoterol tartrate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Fosun Pharma USA Inc.
Application
ANDA214901
Marketing category
ANDA
Marketing start
2025-01-20
Substance
ARFORMOTEROL TARTRATE
Active strength
15 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 42.

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
A214901-001ARFORMOTEROL TARTRATEARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2024-04-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214901-001AN

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
2026-08-18 06:07:402026-07A214901-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2024-04-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214901-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2024-04-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214901-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2024-04-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A214901-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2024-04-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214901-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2024-04-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214901-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2024-04-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214901-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2024-04-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214901-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2024-04-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214901-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2024-04-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214901-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2024-04-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214901-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2024-04-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214901-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2024-04-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214901-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2024-04-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214901-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2024-04-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214901-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2024-04-028072bd15b7f6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214901-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2024-04-02a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A214901-001AN1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214901-001AN1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214901-001AN131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214901-001AN16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214901-001AN1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214901-001AN1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214901-001AN103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214901-001AN12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214901-001AN15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214901-001AN1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214901-001AN1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214901-001AN179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214901-001AN1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214901-001AN11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214901-001AN18072bd15b7f6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214901-001AN1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Arformoterol tartrate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARFORMOTEROL TARTRATE15 ug/2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5P8VJ2I235Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
668956Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
26e06ee1-f9d6-5167-e063-6394a90a6d32Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15e9fde8-93fa-6f6d-5bf2-f94be8a41a73Product name620260202
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72266-259-01Arformoterol tartrate2 mL in 1 VIAL, SINGLE-DOSESOLUTION22
72266-259-01Arformoterol tartrate1 in 1 POUCHSOLUTION12
72266-259-04Arformoterol tartrate2 mL in 1 VIAL, SINGLE-DOSESOLUTION22
72266-259-04Arformoterol tartrate4 in 1 POUCHSOLUTION42
72266-259-30Arformoterol tartrate30 in 1 CARTONSOLUTION302
72266-259-60Arformoterol tartrate15 in 1 CARTONSOLUTION152

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72266-259-01ML - Milliliter72266-2593ba97533-0953-449a-9055-b908585aa1d112025-02-10
72266-259-04ML - Milliliter72266-259b7173bf8-75ca-4080-9990-8cf1f007b73b12025-02-10
72266-259-30ML - Milliliter72266-25957eab2c9-085a-4775-976d-7260eb97366c12025-02-10
72266-259-60ML - Milliliter72266-2596a97925c-28a8-4777-a013-a859fcef212812025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72266-259ARFORMOTEROL TARTRATE SOLUTION [FOSUN PHARMA USA INC.]2Current NDC, 6 package rows20250120_26e06ee1-f9d6-5167-e063-6394a90a6d32.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Arformoterol tartrateARFORMOTEROL TARTRATEFosun Pharma USA Inc.26e06ee1-f9d6-5167-e063-6394a90a6d322024-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214901
application number: ANDA214901
ndc (product): 72266-259

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
668956arformoterol tartrate 15 MCG in 2 ML Inhalation SolutionPSN26e06ee1-f9d6-5167-e063-6394a90a6d322
668956arformoterol 0.0075 MG/ML Inhalation SolutionSCD26e06ee1-f9d6-5167-e063-6394a90a6d322
668956arformoterol 0.0075 MG/ML (arformoterol tartrate 0.011 MG/ML) Inhalation SolutionSY26e06ee1-f9d6-5167-e063-6394a90a6d322
668956arformoterol 15 MCG per 2 ML Inhalation SolutionSY26e06ee1-f9d6-5167-e063-6394a90a6d322

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72266-259-01722660259012 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
72266-259-04722660259042 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
72266-259-307226602593030 POUCH in 1 CARTON (72266-259-30) / 1 VIAL, SINGLE-DOSE in 1 POUCH (72266-259-01) / 2 mL in 1 VIAL, SINGLE-DOSE30 pouch2025-01-20NoNoCurrent
72266-259-607226602596015 POUCH in 1 CARTON (72266-259-60) / 4 VIAL, SINGLE-DOSE in 1 POUCH (72266-259-04) / 2 mL in 1 VIAL, SINGLE-DOSE15 pouch2025-01-20NoNoCurrent