FDA.reportPublic FDA data

Arformoterol Tartrate

Product NDC
42571-464
Requested package NDC
42571-464-73
11-digit product format
425710464
Labeler code
42571
Product ID
42571-464_3306ffee-e664-1534-e063-6294a90ad7ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Arformoterol Tartrate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Micro Labs Limited
Application
ANDA218555
Marketing category
ANDA
Marketing start
2025-05-01
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 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
A218555-001ARFORMOTEROL TARTRATEARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2025-03-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218555-001AN

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 UTC2026-02A218555-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2025-03-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218555-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2025-03-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A218555-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2025-03-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218555-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2025-03-07fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218555-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2025-03-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A218555-001AN1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218555-001AN131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218555-001AN16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218555-001AN1fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218555-001AN1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Arformoterol Tartrate
Listing expiration
2026-12-31

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
6838a595-19cc-454a-96b9-ff83b93881aeAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15e9fde8-93fa-6f6d-5bf2-f94be8a41a73Product name620260202

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42571-464-73Arformoterol Tartrate30 in 1 CARTONSOLUTION302
42571-464-75Arformoterol Tartrate1 in 1 POUCHSOLUTION12
42571-464-75Arformoterol Tartrate2 mL in 1 VIALSOLUTION22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-464-73ML - Milliliter42571-46450e0a0eb-aa7e-4b94-9cab-cea88de6900a12025-12-16
42571-464-75ML - Milliliter42571-46435ef7d22-7ff7-4513-8921-b91a4f983bbc12025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-464ARFORMOTEROL TARTRATE (ARFORMOTEROL TARTRATE) SOLUTION [MICRO LABS LIMITED]2Current NDC, 3 package rows20250501_6838a595-19cc-454a-96b9-ff83b93881ae.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 TARTRATEMicro Labs Limited6838a595-19cc-454a-96b9-ff83b93881ae2025-04-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218555
application number: ANDA218555
ndc (package): 42571-464-73
ndc (product): 42571-464
ndc11 (package): 42571046473

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
668956arformoterol tartrate 15 MCG in 2 ML Inhalation SolutionPSN6838a595-19cc-454a-96b9-ff83b93881ae2
668956arformoterol 0.0075 MG/ML Inhalation SolutionSCD6838a595-19cc-454a-96b9-ff83b93881ae2
668956arformoterol 0.0075 MG/ML (arformoterol tartrate 0.011 MG/ML) Inhalation SolutionSY6838a595-19cc-454a-96b9-ff83b93881ae2
668956arformoterol 15 MCG per 2 ML Inhalation SolutionSY6838a595-19cc-454a-96b9-ff83b93881ae2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42571-464-734257104647330 POUCH in 1 CARTON (42571-464-73) / 1 VIAL in 1 POUCH (42571-464-75) / 2 mL in 1 VIAL30 pouch2025-05-01NoNoCurrent