FDA.reportPublic FDA data

Arformoterol Tartrate Inhalation Solution

Product NDC
76204-026
11-digit product format
762040026
Labeler code
76204
Product ID
76204-026_459f97a4-5026-29d1-e063-6294a90a1a9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Arformoterol Tartrate Inhalation Solution
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Ritedose Pharmaceuticals, LLC
Application
ANDA214736
Marketing category
ANDA
Marketing start
2023-02-27
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 Inhalation Solution
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
76204-026-01Arformoterol Tartrate Inhalation Solution30 in 1 CARTONSOLUTION306
76204-026-01Arformoterol Tartrate Inhalation Solution1 in 1 POUCHSOLUTION16
76204-026-02Arformoterol Tartrate Inhalation Solution1 in 1 POUCHSOLUTION16
76204-026-02Arformoterol Tartrate Inhalation Solution60 in 1 CARTONSOLUTION606
76204-026-55Arformoterol Tartrate Inhalation Solution5 in 1 POUCHSOLUTION56
76204-026-55Arformoterol Tartrate Inhalation Solution12 in 1 CARTONSOLUTION126

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76204-026-01ML - Milliliter76204-0267b362658-e992-48b2-a4da-a4b83090f00712023-07-06
76204-026-02ML - Milliliter76204-02653d3d342-cdfa-49be-b422-a536a70ba4cc12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76204-026ARFORMOTEROL TARTRATE INHALATION SOLUTION SOLUTION [RITEDOSE PHARMACEUTICALS, LLC]4Current NDC, 6 package rows20241219_ef524b4c-68d7-c464-e053-2a95a90a7f96.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
668956arformoterol tartrate 15 MCG in 2 ML Inhalation SolutionPSNef524b4c-68d7-c464-e053-2a95a90a7f966
668956arformoterol 0.0075 MG/ML Inhalation SolutionSCDef524b4c-68d7-c464-e053-2a95a90a7f966
668956arformoterol 0.0075 MG/ML (arformoterol tartrate 0.011 MG/ML) Inhalation SolutionSYef524b4c-68d7-c464-e053-2a95a90a7f966
668956arformoterol 15 MCG per 2 ML Inhalation SolutionSYef524b4c-68d7-c464-e053-2a95a90a7f966

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76204-026-017620400260130 POUCH in 1 CARTON (76204-026-01) / 1 AMPULE in 1 POUCH / 2 mL in 1 AMPULE30 pouch2023-02-27NoNoCurrent
76204-026-027620400260260 POUCH in 1 CARTON (76204-026-02) / 1 AMPULE in 1 POUCH / 2 mL in 1 AMPULE60 pouch2023-02-27NoNoCurrent
76204-026-557620400265512 POUCH in 1 CARTON (76204-026-55) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE12 pouch2023-02-27NoNoCurrent