FDA.reportPublic FDA data

formoterol fumarate

Product NDC
70748-261
11-digit product format
707480261
Labeler code
70748
Product ID
70748-261_7c2eac38-f571-486e-91bb-60f913af5bbc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
formoterol fumarate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA215053
Marketing category
ANDA
Marketing start
2022-11-28
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
70748-261-30formoterol fumarate30 in 1 CARTONSOLUTION306
70748-261-30formoterol fumarate1 in 1 POUCHSOLUTION16
70748-261-60formoterol fumarate60 in 1 CARTONSOLUTION606
70748-261-60formoterol fumarate1 in 1 POUCHSOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70748-261-01ML - Milliliter70748-2616ada2a23-2ef6-4413-8176-cb6d5d51bc8c12022-12-07
70748-261-30ML - Milliliter70748-2619d014c76-02b2-44b4-a0eb-afef8800439412022-12-07
70748-261-60ML - Milliliter70748-261ea626c69-8747-4a17-9178-0f6716f7d8f112022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70748-261FORMOTEROL FUMARATE SOLUTION [LUPIN PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 4 package rows20250123_44284e8c-0503-48c4-ae71-a0d6b865665d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1246319formoterol fumarate 20 MCG in 2 ML Inhalation SolutionPSN44284e8c-0503-48c4-ae71-a0d6b865665d6
1246319formoterol fumarate 0.01 MG/ML Inhalation SolutionSCD44284e8c-0503-48c4-ae71-a0d6b865665d6
1246319formoterol fumarate 20 MCG per 2 ML Inhalation SolutionSY44284e8c-0503-48c4-ae71-a0d6b865665d6
1246319formoterol fumarate 20 MCG/2 ML Inhalation SolutionSY44284e8c-0503-48c4-ae71-a0d6b865665d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70748-261-307074802613030 POUCH in 1 CARTON (70748-261-30) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL30 pouch2022-11-280000-00-00NoNoCurrent
70748-261-607074802616060 POUCH in 1 CARTON (70748-261-60) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL60 pouch2022-11-280000-00-00NoNoCurrent