FDA.reportPublic FDA data

Arformoterol tartrate

Product NDC
70748-175
11-digit product format
707480175
Labeler code
70748
Product ID
70748-175_65d81c00-8791-4937-8e25-4abfc9790e4b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Arformoterol tartrate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA213068
Marketing category
ANDA
Marketing start
2022-07-27
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
70748-175-30Arformoterol tartrate30 in 1 CARTONSOLUTION307
70748-175-30Arformoterol tartrate1 in 1 POUCHSOLUTION17
70748-175-60Arformoterol tartrate1 in 1 POUCHSOLUTION17
70748-175-60Arformoterol tartrate60 in 1 CARTONSOLUTION607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70748-175-01ML - Milliliter70748-17599192e32-1cb4-41f7-a235-077508e219f412023-01-09
70748-175-30ML - Milliliter70748-1759d964bb8-6719-4082-838c-b392689c6fb612022-06-06
70748-175-60ML - Milliliter70748-175e2b079ee-6237-4629-b391-a241abf4f3d512022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70748-175ARFORMOTEROL TARTRATE SOLUTION [LUPIN PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 4 package rows20250321_cf1f2d1b-0455-4113-9647-507faf49fdd0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
668956arformoterol tartrate 15 MCG in 2 ML Inhalation SolutionPSNcf1f2d1b-0455-4113-9647-507faf49fdd07
668956arformoterol 0.0075 MG/ML Inhalation SolutionSCDcf1f2d1b-0455-4113-9647-507faf49fdd07
668956arformoterol 0.0075 MG/ML (arformoterol tartrate 0.011 MG/ML) Inhalation SolutionSYcf1f2d1b-0455-4113-9647-507faf49fdd07
668956arformoterol 15 MCG per 2 ML Inhalation SolutionSYcf1f2d1b-0455-4113-9647-507faf49fdd07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70748-175-307074801753030 POUCH in 1 CARTON (70748-175-30) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE30 pouch2022-07-270000-00-00NoNoCurrent
70748-175-607074801756060 POUCH in 1 CARTON (70748-175-60) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE60 pouch2022-07-270000-00-00NoNoCurrent