FDA.reportPublic FDA data

Arformoterol Tartrate

Product NDC
60687-770
11-digit product format
606870770
Labeler code
60687
Product ID
60687-770_04b2262f-ade9-c53b-e063-6294a90a3610
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Arformoterol Tartrate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
American Health Packaging
Application
ANDA215385
Marketing category
ANDA
Marketing start
2024-04-01
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
60687-770-79Arformoterol Tartrate2 mL in 1 VIAL, SINGLE-DOSESOLUTION23
60687-770-83Arformoterol Tartrate1 in 1 POUCHSOLUTION13
60687-770-83Arformoterol Tartrate30 in 1 CARTONSOLUTION303
60687-770-84Arformoterol Tartrate60 in 1 CARTONSOLUTION603
60687-770-84Arformoterol Tartrate1 in 1 POUCHSOLUTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-770-79ML - Milliliter60687-770102c8311-7535-4343-9a74-e9364f81c97012023-09-05
60687-770-83ML - Milliliter60687-770885eb999-ef78-45c7-acd9-644b5917a45912023-09-05
60687-770-84ML - Milliliter60687-77011b0d2e1-c54b-447e-9f03-b61062176ffd12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-770ARFORMOTEROL TARTRATE SOLUTION [AMERICAN HEALTH PACKAGING]3Current NDC, 5 package rows20240402_bb1a6643-f280-4f02-a824-0428a2b82d3c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
668956arformoterol tartrate 15 MCG in 2 ML Inhalation SolutionPSNbb1a6643-f280-4f02-a824-0428a2b82d3c3
668956arformoterol 0.0075 MG/ML Inhalation SolutionSCDbb1a6643-f280-4f02-a824-0428a2b82d3c3
668956arformoterol 0.0075 MG/ML (arformoterol tartrate 0.011 MG/ML) Inhalation SolutionSYbb1a6643-f280-4f02-a824-0428a2b82d3c3
668956arformoterol 15 MCG per 2 ML Inhalation SolutionSYbb1a6643-f280-4f02-a824-0428a2b82d3c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-770-79606870770792 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
60687-770-836068707708330 POUCH in 1 CARTON (60687-770-83) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE (60687-770-79) 30 pouch2024-04-01NoNoHistorical
60687-770-846068707708460 POUCH in 1 CARTON (60687-770-84) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE (60687-770-79) 60 pouch2024-04-01NoNoHistorical