FDA.reportPublic FDA data

Arformoterol Tartrate Inhalation

Product NDC
70436-151
11-digit product format
704360151
Labeler code
70436
Product ID
70436-151_3bd6ebed-0405-445a-8613-ae20b2e70703
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Arformoterol Tartrate Inhalation
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Slate Run Pharmaceuticals
Application
ANDA213762
Marketing category
ANDA
Marketing start
2021-06-22
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 Inhalation
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
70436-151-19Arformoterol Tartrate Inhalation1 in 1 POUCHSOLUTION14
70436-151-19Arformoterol Tartrate Inhalation2 mL in 1 VIALSOLUTION24
70436-151-20Arformoterol Tartrate Inhalation4 in 1 POUCHSOLUTION44
70436-151-20Arformoterol Tartrate Inhalation2 mL in 1 VIALSOLUTION24
70436-151-57Arformoterol Tartrate Inhalation30 in 1 CARTONSOLUTION304
70436-151-58Arformoterol Tartrate Inhalation15 in 1 CARTONSOLUTION154

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70436-151-19ML - Milliliter70436-151a241f59e-95a6-4717-8000-bfcabc83fb5912021-07-15
70436-151-20ML - Milliliter70436-1512d91895f-1c6f-432e-9b96-be944954704812021-07-15
70436-151-57ML - Milliliter70436-15115c2222e-6bb8-4f63-8b67-5439d08cd1da12021-07-15
70436-151-58ML - Milliliter70436-15174131405-0f95-4f38-91aa-f32ac46b49e712021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-151ARFORMOTEROL TARTRATE INHALATION SOLUTION [SLATE RUN PHARMACEUTICALS]4Current NDC, Legacy NDC, 6 package rows20230127_7d639762-091b-471e-9355-c2f4737676a2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
668956arformoterol tartrate 15 MCG in 2 ML Inhalation SolutionPSN7d639762-091b-471e-9355-c2f4737676a24
668956arformoterol 0.0075 MG/ML Inhalation SolutionSCD7d639762-091b-471e-9355-c2f4737676a24
668956arformoterol 0.0075 MG/ML (arformoterol tartrate 0.011 MG/ML) Inhalation SolutionSY7d639762-091b-471e-9355-c2f4737676a24
668956arformoterol 15 MCG per 2 ML Inhalation SolutionSY7d639762-091b-471e-9355-c2f4737676a24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70436-151-19704360151191 in 1 POUCHHistorical
70436-151-20704360151204 in 1 POUCHHistorical
70436-151-577043601515730 POUCH in 1 CARTON (70436-151-57) / 1 VIAL in 1 POUCH (70436-151-19) / 2 mL in 1 VIAL30 pouch2021-06-220000-00-00NoNoCurrent
70436-151-587043601515815 POUCH in 1 CARTON (70436-151-58) / 4 VIAL in 1 POUCH (70436-151-20) / 2 mL in 1 VIAL15 pouch2021-06-220000-00-00NoNoCurrent