FDA.reportPublic FDA data

arformoterol tartrate

Product NDC
69097-168
11-digit product format
690970168
Labeler code
69097
Product ID
69097-168_07b162cc-b71c-4750-a10b-2db80625012f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
arformoterol tartrate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Cipla USA Inc.
Application
ANDA207306
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
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
69097-168-32arformoterol tartrate2 mL in 1 VIAL, SINGLE-DOSESOLUTION26
69097-168-32arformoterol tartrate1 in 1 POUCHSOLUTION16
69097-168-48arformoterol tartrate5 in 1 POUCHSOLUTION56
69097-168-48arformoterol tartrate2 mL in 1 VIAL, SINGLE-DOSESOLUTION26
69097-168-53arformoterol tartrate30 in 1 CARTONSOLUTION306
69097-168-64arformoterol tartrate12 in 1 CARTONSOLUTION126
69097-168-64arformoterol tartrate5 in 1 POUCHSOLUTION56
69097-168-87arformoterol tartrate6 in 1 CARTONSOLUTION66

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-168-32ML - Milliliter69097-168e6d95ec8-9eaf-40dc-bf4b-ae2f4691a78a12022-11-07
69097-168-48ML - Milliliter69097-16889d10222-32eb-4978-a4fc-24c86912defb12021-07-15
69097-168-53ML - Milliliter69097-16875f40b72-7f5c-41f3-be8d-acbc95eb787212022-11-07
69097-168-64ML - Milliliter69097-168134b6b97-3d34-41aa-9dcd-29c314f1b5af12021-07-15
69097-168-87ML - Milliliter69097-16814f05a90-43fa-49f3-976c-1305f323443812021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-168ARFORMOTEROL TARTRATE SOLUTION [CIPLA USA INC.]4Current NDC, Legacy NDC, 8 package rows20220716_70071afd-5323-4019-aca5-5534278829dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
668956arformoterol tartrate 15 MCG in 2 ML Inhalation SolutionPSN70071afd-5323-4019-aca5-5534278829dc6
668956arformoterol 0.0075 MG/ML Inhalation SolutionSCD70071afd-5323-4019-aca5-5534278829dc6
668956arformoterol 0.0075 MG/ML (arformoterol tartrate 0.011 MG/ML) Inhalation SolutionSY70071afd-5323-4019-aca5-5534278829dc6
668956arformoterol 15 MCG per 2 ML Inhalation SolutionSY70071afd-5323-4019-aca5-5534278829dc6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-168-32690970168322 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
69097-168-48690970168485 in 1 POUCHHistorical
69097-168-536909701685330 POUCH in 1 CARTON (69097-168-53) / 1 VIAL, SINGLE-DOSE in 1 POUCH (69097-168-32) / 2 mL in 1 VIAL, SINGLE-DOSE30 pouch2022-01-270000-00-00NoNoCurrent
69097-168-646909701686412 POUCH in 1 CARTON (69097-168-64) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE12 pouch2021-06-220000-00-00NoNoCurrent
69097-168-87690970168876 POUCH in 1 CARTON (69097-168-87) / 5 VIAL, SINGLE-DOSE in 1 POUCH (69097-168-48) / 2 mL in 1 VIAL, SINGLE-DOSE6 pouch2021-06-220000-00-00NoNoCurrent