FDA.reportPublic FDA data

arformoterol tartrate

Product NDC
70756-612
11-digit product format
707560612
Labeler code
70756
Product ID
70756-612_0cf1c98c-4caf-4eff-b603-6c4b8dd6e148
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
arformoterol tartrate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Lifestar Pharma LLC
Application
ANDA216128
Marketing category
ANDA
Marketing start
2022-11-15
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
70756-612-12arformoterol tartrate2 mL in 1 VIALSOLUTION27
70756-612-12arformoterol tartrate1 in 1 POUCHSOLUTION17
70756-612-44arformoterol tartrate4 in 1 POUCHSOLUTION47
70756-612-44arformoterol tartrate2 mL in 1 VIALSOLUTION27
70756-612-60arformoterol tartrate60 in 1 CARTONSOLUTION607
70756-612-70arformoterol tartrate30 in 1 CARTONSOLUTION307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70756-612-12ML - Milliliter70756-6123509941c-d607-438a-93a0-a48e6e96c85612023-02-06
70756-612-44ML - Milliliter70756-612541aee7f-c42d-45df-b25b-eae8c4021df812023-02-06
70756-612-60ML - Milliliter70756-61272585ec1-eb50-444f-861c-a4339a8b232012023-02-06
70756-612-70ML - Milliliter70756-612966f0d2d-ebca-44e3-a8b2-568a5af5597212023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-612ARFORMOTEROL TARTRATE SOLUTION [LIFESTAR PHARMA LLC]4Current NDC, Legacy NDC, 6 package rows20230318_e9eb1ac7-57aa-4ef8-aac3-14def5b883d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
668956arformoterol tartrate 15 MCG in 2 ML Inhalation SolutionPSNe9eb1ac7-57aa-4ef8-aac3-14def5b883d07
668956arformoterol 0.0075 MG/ML Inhalation SolutionSCDe9eb1ac7-57aa-4ef8-aac3-14def5b883d07
668956arformoterol 0.0075 MG/ML (arformoterol tartrate 0.011 MG/ML) Inhalation SolutionSYe9eb1ac7-57aa-4ef8-aac3-14def5b883d07
668956arformoterol 15 MCG per 2 ML Inhalation SolutionSYe9eb1ac7-57aa-4ef8-aac3-14def5b883d07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70756-612-12707560612122 mL in 1 VIAL2 mlHistorical
70756-612-44707560612444 in 1 POUCHHistorical
70756-612-607075606126060 POUCH in 1 CARTON (70756-612-60) / 4 VIAL in 1 POUCH (70756-612-44) / 2 mL in 1 VIAL60 pouch2022-11-150000-00-00NoNoCurrent
70756-612-707075606127030 POUCH in 1 CARTON (70756-612-70) / 1 VIAL in 1 POUCH (70756-612-12) / 2 mL in 1 VIAL30 pouch2022-11-150000-00-00NoNoCurrent