FDA.reportPublic FDA data

Formoterol fumarate

Product NDC
72603-620
11-digit product format
726030620
Labeler code
72603
Product ID
72603-620_56c96143-8313-4b0f-a070-64a0a9b72e08
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Formoterol fumarate dihydrate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
NorthStar RxLLC
Application
ANDA215883
Marketing category
ANDA
Marketing start
2024-07-01
Substance
FORMOTEROL FUMARATE
Active strength
20 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
Formoterol fumarate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FORMOTEROL FUMARATE20 ug/2mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW34SHF8J2K
Rxcui1246319

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0c06c4f4-ea2d-4e6a-a22a-0cf292716367Product name420250303
9ab9f611-cedd-47ea-a83c-0489c8c04fc6Product name120231006
a03aea00-1d8b-bfad-a82e-f52f68676f63Product name220221216
7d8c8d5a-f174-4e6b-97b1-6fd615c5df9aProduct name120210204
1cbe9071-502b-482d-9c24-839b43446576Product name120200123
58f15a44-d9d2-4d61-a39d-7f0223302a8fProduct name120190702
ce066c73-ca6f-49fc-83d4-d3cf6728e8a1Product name120160616

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72603-620-01Formoterol fumarate2 mL in 1 VIALSOLUTION22
72603-620-01Formoterol fumarate1 in 1 POUCHSOLUTION12
72603-620-04Formoterol fumarate4 in 1 POUCHSOLUTION42
72603-620-04Formoterol fumarate2 mL in 1 VIALSOLUTION22
72603-620-30Formoterol fumarate30 in 1 CARTONSOLUTION302
72603-620-60Formoterol fumarate60 in 1 CARTONSOLUTION602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-620FORMOTEROL FUMARATE (FORMOTEROL FUMARATE DIHYDRATE) SOLUTION [NORTHSTAR RXLLC]1Current NDC, 6 package rows20240701_4dbb9620-5731-40d9-8258-2977ecc781c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1246319formoterol fumarate 20 MCG in 2 ML Inhalation SolutionPSN4dbb9620-5731-40d9-8258-2977ecc781c42
1246319formoterol fumarate 0.01 MG/ML Inhalation SolutionSCD4dbb9620-5731-40d9-8258-2977ecc781c42
1246319formoterol fumarate 20 MCG per 2 ML Inhalation SolutionSY4dbb9620-5731-40d9-8258-2977ecc781c42
1246319formoterol fumarate 20 MCG/2 ML Inhalation SolutionSY4dbb9620-5731-40d9-8258-2977ecc781c42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-620-01726030620012 mL in 1 VIAL2 mlHistorical
72603-620-04726030620044 in 1 POUCHHistorical
72603-620-307260306203030 POUCH in 1 CARTON (72603-620-30) / 1 VIAL in 1 POUCH (72603-620-01) / 2 mL in 1 VIAL30 pouch2024-07-01NoNoCurrent
72603-620-607260306206060 POUCH in 1 CARTON (72603-620-60) / 4 VIAL in 1 POUCH (72603-620-04) / 2 mL in 1 VIAL60 pouch2024-07-01NoNoCurrent