FDA.reportPublic FDA data

Arformoterol Tartrate

Product NDC
62756-277
11-digit product format
627560277
Labeler code
62756
Product ID
62756-277_5314ef39-4fbf-4a1a-a101-efcc1e505fdf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Arformoterol Tartrate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA215385
Marketing category
ANDA
Marketing start
2022-05-28
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
2027-12-31
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
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
62756-277-02Arformoterol Tartrate6 in 1 CARTONSOLUTION64
62756-277-02Arformoterol Tartrate5 in 1 POUCHSOLUTION54
62756-277-03Arformoterol Tartrate12 in 1 CARTONSOLUTION124
62756-277-03Arformoterol Tartrate5 in 1 POUCHSOLUTION54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62756-277-02ML - Milliliter62756-277f42da840-1ad2-43f0-a73c-b77260d5f48c12022-07-06
62756-277-03ML - Milliliter62756-277de466b24-ecec-4dd7-8dfd-3c07c9738db612022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-277ARFORMOTEROL TARTRATE SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]3Current NDC, Legacy NDC, 4 package rows20220528_f1005878-0c48-4b9a-843e-b6cf6b8bb251.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
668956arformoterol tartrate 15 MCG in 2 ML Inhalation SolutionPSNf1005878-0c48-4b9a-843e-b6cf6b8bb2514
668956arformoterol 0.0075 MG/ML Inhalation SolutionSCDf1005878-0c48-4b9a-843e-b6cf6b8bb2514
668956arformoterol 0.0075 MG/ML (arformoterol tartrate 0.011 MG/ML) Inhalation SolutionSYf1005878-0c48-4b9a-843e-b6cf6b8bb2514
668956arformoterol 15 MCG per 2 ML Inhalation SolutionSYf1005878-0c48-4b9a-843e-b6cf6b8bb2514
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 startMarketing endSampleExclude flagStatus
62756-277-02627560277026 POUCH in 1 CARTON (62756-277-02) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE6 pouch2022-05-280000-00-00NoNoCurrent
62756-277-036275602770312 POUCH in 1 CARTON (62756-277-03) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE12 pouch2022-05-280000-00-00NoNoCurrent