FDA.reportPublic FDA data

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

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 Identifiers#

Field, Values table
FieldValues
Unii5P8VJ2I235

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

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 pouch2025-01-20NoNoHistorical
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 pouch2025-01-20NoNoHistorical