FDA.reportPublic FDA data

Arformoterol Tartrate

Product NDC
42571-464
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

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 Identifiers#

Field, Values table
FieldValues
Unii5P8VJ2I235
Rxcui668956

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

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
42571-464-75425710464751 in 1 POUCHHistorical