FDA.reportPublic FDA data

Formoterol fumarate

Product NDC
0904-7454
11-digit product format
009047454
Labeler code
0904
Product ID
0904-7454_9aded1f3-a8e1-499c-84d2-e6d12c5d6322
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Formoterol fumarate dihydrate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Major Pharmaceuticals
Application
ANDA215883
Marketing category
ANDA
Marketing start
2024-11-11
Marketing end
2026-07-31
Substance
FORMOTEROL FUMARATE
Active strength
20 ug/2mL
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Formoterol fumarate

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
0904-7454-11Formoterol fumarate30 in 1 CARTONSOLUTION303
0904-7454-14Formoterol fumarate60 in 1 CARTONSOLUTION603
0904-7454-55Formoterol fumarate4 in 1 POUCHSOLUTION43
0904-7454-55Formoterol fumarate2 mL in 1 VIALSOLUTION23
0904-7454-98Formoterol fumarate1 in 1 POUCHSOLUTION13
0904-7454-98Formoterol fumarate2 mL in 1 VIALSOLUTION23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7454-11ML - Milliliter0904-7454aedebeb0-8cdd-4084-a8af-4f61343177c912024-11-05
0904-7454-14ML - Milliliter0904-74544fc19c40-42a1-4ec1-adf4-0360e0a73b6412024-11-05
0904-7454-55ML - Milliliter0904-7454849ed4d2-4041-4ab2-beaf-caa367a7a99312024-11-05
0904-7454-98ML - Milliliter0904-7454ae7381b9-ee27-4b43-be4c-89044240cc6912024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7454FORMOTEROL FUMARATE (FORMOTEROL FUMARATE DIHYDRATE) SOLUTION [MAJOR PHARMACEUTICALS]2Current NDC, 6 package rows20241113_c77e5f67-01bc-4704-8120-0e2e3d020482.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1246319formoterol fumarate 20 MCG in 2 ML Inhalation SolutionPSNc77e5f67-01bc-4704-8120-0e2e3d0204823
1246319formoterol fumarate 0.01 MG/ML Inhalation SolutionSCDc77e5f67-01bc-4704-8120-0e2e3d0204823
1246319formoterol fumarate 20 MCG per 2 ML Inhalation SolutionSYc77e5f67-01bc-4704-8120-0e2e3d0204823
1246319formoterol fumarate 20 MCG/2 ML Inhalation SolutionSYc77e5f67-01bc-4704-8120-0e2e3d0204823

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7454-110090474541130 POUCH in 1 CARTON (0904-7454-11) / 1 VIAL in 1 POUCH (0904-7454-98) / 2 mL in 1 VIAL30 pouch2024-11-112026-07-31NoNoHistorical
0904-7454-140090474541460 POUCH in 1 CARTON (0904-7454-14) / 4 VIAL in 1 POUCH (0904-7454-55) / 2 mL in 1 VIAL60 pouch2024-11-112026-07-31NoNoHistorical
0904-7454-55009047454554 in 1 POUCHHistorical
0904-7454-98009047454981 in 1 POUCHHistorical