FDA.reportPublic FDA data

Formoterol Fumarate

Product NDC
50742-394
11-digit product format
507420394
Labeler code
50742
Product ID
50742-394_36df181b-7f3a-3ad2-e063-6294a90ab756
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Formoterol Fumarate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA216426
Marketing category
ANDA
Marketing start
2025-06-05
Substance
FORMOTEROL FUMARATE
Active strength
.02 mg/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 FUMARATE.02 mg/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
50742-394-01Formoterol Fumarate1 in 1 POUCHSOLUTION14
50742-394-01Formoterol Fumarate2 mL in 1 VIAL, SINGLE-DOSESOLUTION24
50742-394-30Formoterol Fumarate30 in 1 CARTONSOLUTION304
50742-394-60Formoterol Fumarate1 in 1 POUCHSOLUTION14
50742-394-60Formoterol Fumarate60 in 1 CARTONSOLUTION604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-394-01ML - Milliliter50742-3940b3294ec-8284-4f52-8b48-6e68b0df2ed812025-08-11
50742-394-30ML - Milliliter50742-3949f994220-3f70-4f61-8338-0e8e2fef4a9f12025-08-11
50742-394-60ML - Milliliter50742-394e2ae1b13-6d44-417c-abc7-c1b682fc4dd312025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-394FORMOTEROL FUMARATE SOLUTION [INGENUS PHARMACEUTICALS, LLC]3Current NDC, 5 package rows20250317_303479a7-80fb-1f6d-e063-6394a90abbda.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1246319formoterol fumarate 20 MCG in 2 ML Inhalation SolutionPSN303479a7-80fb-1f6d-e063-6394a90abbda4
1246319formoterol fumarate 0.01 MG/ML Inhalation SolutionSCD303479a7-80fb-1f6d-e063-6394a90abbda4
1246319formoterol fumarate 20 MCG per 2 ML Inhalation SolutionSY303479a7-80fb-1f6d-e063-6394a90abbda4
1246319formoterol fumarate 20 MCG/2 ML Inhalation SolutionSY303479a7-80fb-1f6d-e063-6394a90abbda4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50742-394-01507420394011 in 1 POUCHHistorical
50742-394-305074203943030 POUCH in 1 CARTON (50742-394-30) / 1 VIAL, SINGLE-DOSE in 1 POUCH (50742-394-01) / 2 mL in 1 VIAL, SINGLE-DOSE30 pouch2025-06-06NoNoHistorical
50742-394-605074203946060 POUCH in 1 CARTON (50742-394-60) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE60 pouch2025-06-05NoNoHistorical