FDA.reportPublic FDA data

Arformoterol tartrate

Product NDC
62332-633
11-digit product format
623320633
Labeler code
62332
Product ID
62332-633_10d5ad75-2475-42de-9acc-5c7fdd044bb6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Arformoterol tartrate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA214779
Marketing category
ANDA
Marketing start
2022-05-10
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
62332-633-01Arformoterol tartrate01 in 1 POUCHSOLUTION0110
62332-633-01Arformoterol tartrate2 mL in 1 VIALSOLUTION210
62332-633-04Arformoterol tartrate4 in 1 POUCHSOLUTION410
62332-633-04Arformoterol tartrate2 mL in 1 VIALSOLUTION210
62332-633-30Arformoterol tartrate30 in 1 CARTONSOLUTION3010
62332-633-60Arformoterol tartrate60 in 1 CARTONSOLUTION6010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-633-01ML - Milliliter62332-63323b2f18a-685d-4aef-81b6-a6dfe64d596412023-10-16
62332-633-04ML - Milliliter62332-633617f80ed-f7f6-40bd-9448-4834d3c2904a12023-10-16
62332-633-30ML - Milliliter62332-633a2a9d968-47cf-4de5-b094-1d0eae4f95e912023-10-16
62332-633-60ML - Milliliter62332-6338028c26a-d36f-452f-838b-54ca2dcf354612023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-633ARFORMOTEROL TARTRATE SOLUTION [ALEMBIC PHARMACEUTICALS INC.]9Current NDC, Legacy NDC, 6 package rows20240110_f2feda53-54b9-4e40-8a01-9e7b45cb3d8c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
668956arformoterol tartrate 15 MCG in 2 ML Inhalation SolutionPSNf2feda53-54b9-4e40-8a01-9e7b45cb3d8c10
668956arformoterol 0.0075 MG/ML Inhalation SolutionSCDf2feda53-54b9-4e40-8a01-9e7b45cb3d8c10
668956arformoterol 0.0075 MG/ML (arformoterol tartrate 0.011 MG/ML) Inhalation SolutionSYf2feda53-54b9-4e40-8a01-9e7b45cb3d8c10
668956arformoterol 15 MCG per 2 ML Inhalation SolutionSYf2feda53-54b9-4e40-8a01-9e7b45cb3d8c10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-633-016233206330101 in 1 POUCHHistorical
62332-633-04623320633044 in 1 POUCHHistorical
62332-633-306233206333030 POUCH in 1 CARTON (62332-633-30) / 1 VIAL in 1 POUCH (62332-633-01) / 2 mL in 1 VIAL30 pouch2022-05-100000-00-00NoNoCurrent
62332-633-606233206336060 POUCH in 1 CARTON (62332-633-60) / 4 VIAL in 1 POUCH (62332-633-04) / 2 mL in 1 VIAL60 pouch2022-05-100000-00-00NoNoCurrent