FDA.reportPublic FDA data

FORMOTEROL FUMARATE

Product NDC
0378-1631
11-digit product format
003781631
Labeler code
0378
Product ID
0378-1631_db19667d-88cd-47ab-adb5-894959822801
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
formoterol fumarate dihydrate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Mylan Pharmaceuticals Inc.
Application
NDA022007
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2021-06-22
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
FORMOTEROL FUMARATE
Listing expiration
2026-12-31

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
0378-1631-32FORMOTEROL FUMARATE2 mL in 1 VIALSOLUTION25
0378-1631-32FORMOTEROL FUMARATE1 in 1 POUCHSOLUTION15
0378-1631-91FORMOTEROL FUMARATE60 in 1 CARTONSOLUTION605
0378-1631-91FORMOTEROL FUMARATE1 in 1 POUCHSOLUTION15
0378-1631-93FORMOTEROL FUMARATE30 in 1 CARTONSOLUTION305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-1631-32ML - Milliliter0378-1631edfcf87f-19fd-4e41-9b56-07d24319e4b312021-07-15
0378-1631-91ML - Milliliter0378-163168e5c3f4-ec80-4d7e-8056-c7988110aeb112021-07-15
0378-1631-93ML - Milliliter0378-16318e592dd4-af06-40a1-aceb-6643967f341d12021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-1631FORMOTEROL FUMARATE (FORMOTEROL FUMARATE DIHYDRATE) SOLUTION [MYLAN PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 5 package rows20250123_6c1a6c53-af85-4220-9ce3-2373e0928f7f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1246319formoterol fumarate 20 MCG in 2 ML Inhalation SolutionPSN6c1a6c53-af85-4220-9ce3-2373e0928f7f5
1246319formoterol fumarate 0.01 MG/ML Inhalation SolutionSCD6c1a6c53-af85-4220-9ce3-2373e0928f7f5
1246319formoterol fumarate 20 MCG per 2 ML Inhalation SolutionSY6c1a6c53-af85-4220-9ce3-2373e0928f7f5
1246319formoterol fumarate 20 MCG/2 ML Inhalation SolutionSY6c1a6c53-af85-4220-9ce3-2373e0928f7f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-1631-32003781631322 mL in 1 VIAL2 mlHistorical
0378-1631-910037816319160 POUCH in 1 CARTON (0378-1631-91) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL60 pouch2021-06-220000-00-00NoNoCurrent
0378-1631-930037816319330 POUCH in 1 CARTON (0378-1631-93) / 1 VIAL in 1 POUCH (0378-1631-32) / 2 mL in 1 VIAL30 pouch2021-06-220000-00-00NoNoCurrent