FDA.reportPublic FDA data

arformoterol tartrate

Product NDC
72603-208
11-digit product format
726030208
Labeler code
72603
Product ID
72603-208_c3d670fd-671b-4c32-a9ca-448dc6a49c66
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
arformoterol tartrate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
NorthStar RxLLC
Application
ANDA216128
Marketing category
ANDA
Marketing start
2024-06-01
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72603-208-01arformoterol tartrate2 mL in 1 VIALSOLUTION23
72603-208-01arformoterol tartrate1 in 1 POUCHSOLUTION13
72603-208-04arformoterol tartrate4 in 1 POUCHSOLUTION43
72603-208-04arformoterol tartrate2 mL in 1 VIALSOLUTION23
72603-208-30arformoterol tartrate30 in 1 CARTONSOLUTION303
72603-208-60arformoterol tartrate60 in 1 CARTONSOLUTION603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-208-01ML - Milliliter72603-20881d9b8f8-54f9-470c-a7d4-ce8baabfb37b12024-07-12
72603-208-04ML - Milliliter72603-208ad0f1f03-a740-480b-86c4-95da8bbbe21112024-07-12
72603-208-30ML - Milliliter72603-208d24c6633-8607-4f6a-aa92-1a5cd970734212024-06-10
72603-208-60ML - Milliliter72603-208b2be14e3-43eb-4db4-8097-e898b5db8b7512024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-208ARFORMOTEROL TARTRATE SOLUTION [NORTHSTAR RXLLC]2Current NDC, 6 package rows20240601_6a498c49-042f-481f-bc5c-a2fc00dc5668.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
668956arformoterol tartrate 15 MCG in 2 ML Inhalation SolutionPSN6a498c49-042f-481f-bc5c-a2fc00dc56683
668956arformoterol 0.0075 MG/ML Inhalation SolutionSCD6a498c49-042f-481f-bc5c-a2fc00dc56683
668956arformoterol 0.0075 MG/ML (arformoterol tartrate 0.011 MG/ML) Inhalation SolutionSY6a498c49-042f-481f-bc5c-a2fc00dc56683
668956arformoterol 15 MCG per 2 ML Inhalation SolutionSY6a498c49-042f-481f-bc5c-a2fc00dc56683

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-208-01726030208012 mL in 1 VIAL2 mlHistorical
72603-208-04726030208044 in 1 POUCHHistorical
72603-208-307260302083030 POUCH in 1 CARTON (72603-208-30) / 1 VIAL in 1 POUCH (72603-208-01) / 2 mL in 1 VIAL30 pouch2024-06-01NoNoCurrent
72603-208-607260302086060 POUCH in 1 CARTON (72603-208-60) / 4 VIAL in 1 POUCH (72603-208-04) / 2 mL in 1 VIAL60 pouch2024-06-01NoNoCurrent