FDA.reportPublic FDA data

arformoterol tartrate

Product NDC
43598-777
11-digit product format
435980777
Labeler code
43598
Product ID
43598-777_a718ab1b-b96b-bed2-24d1-b74c0277daed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
arformoterol tartrate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Dr. Reddy's Laboratories, Inc.
Application
ANDA215032
Marketing category
ANDA
Marketing start
2024-09-02
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
43598-777-11arformoterol tartrate1 in 1 POUCHSOLUTION14
43598-777-11arformoterol tartrate2 mL in 1 VIAL, SINGLE-DOSESOLUTION24
43598-777-30arformoterol tartrate30 in 1 CARTONSOLUTION304
43598-777-48arformoterol tartrate2 mL in 1 VIAL, SINGLE-DOSESOLUTION24
43598-777-48arformoterol tartrate4 in 1 POUCHSOLUTION44
43598-777-60arformoterol tartrate15 in 1 CARTONSOLUTION154

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-777-30ML - Milliliter43598-777db3ff7d9-664f-4feb-b68e-90de418e9d4712025-02-10
43598-777-60ML - Milliliter43598-7775a238ee7-e962-4ef7-851a-4ee19e497f0412025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-777ARFORMOTEROL TARTRATE SOLUTION [DR. REDDY'S LABORATORIES, INC.]4Current NDC, 6 package rows20240902_d8843369-b0d5-6f0d-1fcd-0c49002df755.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
668956arformoterol tartrate 15 MCG in 2 ML Inhalation SolutionPSNd8843369-b0d5-6f0d-1fcd-0c49002df7554
668956arformoterol 0.0075 MG/ML Inhalation SolutionSCDd8843369-b0d5-6f0d-1fcd-0c49002df7554
668956arformoterol 0.0075 MG/ML (arformoterol tartrate 0.011 MG/ML) Inhalation SolutionSYd8843369-b0d5-6f0d-1fcd-0c49002df7554
668956arformoterol 15 MCG per 2 ML Inhalation SolutionSYd8843369-b0d5-6f0d-1fcd-0c49002df7554

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43598-777-11435980777111 in 1 POUCHHistorical
43598-777-304359807773030 POUCH in 1 CARTON (43598-777-30) / 1 VIAL, SINGLE-DOSE in 1 POUCH (43598-777-11) / 2 mL in 1 VIAL, SINGLE-DOSE30 pouch2024-09-02NoNoHistorical
43598-777-48435980777482 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
43598-777-604359807776015 POUCH in 1 CARTON (43598-777-60) / 4 VIAL, SINGLE-DOSE in 1 POUCH (43598-777-48) / 2 mL in 1 VIAL, SINGLE-DOSE15 pouch2024-09-02NoNoHistorical