Formoterol Fumarate

Product NDC
62332-655
11-digit product format
623320655
Labeler code
62332
Product ID
62332-655_99e63a2d-5d11-43b4-ba83-1d64f3fc3914
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Formoterol Fumarate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA215078
Marketing category
ANDA
Marketing start
2021-11-22
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9ab9f611-cedd-47ea-a83c-0489c8c04fc6Product name120231006
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
a03aea00-1d8b-bfad-a82e-f52f68676f63Product name220221216
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
7d8c8d5a-f174-4e6b-97b1-6fd615c5df9aProduct name120210204
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
1cbe9071-502b-482d-9c24-839b43446576Product name120200123
58f15a44-d9d2-4d61-a39d-7f0223302a8fProduct name120190702
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ce066c73-ca6f-49fc-83d4-d3cf6728e8a1Product name120160616
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62332-655-01Formoterol Fumarate2 mL in 1 VIALSOLUTION212
62332-655-01Formoterol Fumarate1 in 1 POUCHSOLUTION112
62332-655-30Formoterol Fumarate30 in 1 CARTONSOLUTION3012
62332-655-60Formoterol Fumarate1 in 1 POUCHSOLUTION112
62332-655-60Formoterol Fumarate60 in 1 CARTONSOLUTION6012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-655-01ML - Milliliter62332-6558d83b796-16a2-4fcc-82e7-50d53b8dd28a12022-03-09
62332-655-30ML - Milliliter62332-655c44f1035-778c-4ce1-91b5-e5f9124e151412022-03-09
62332-655-60ML - Milliliter62332-65559f28dc4-24d8-44af-ad2e-2f6a66a0b15b12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-655FORMOTEROL FUMARATE SOLUTION [ALEMBIC PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 5 package rows20250207_07afdf7e-c480-4806-b469-a6a460522bc0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1246319formoterol fumarate 20 MCG in 2 ML Inhalation SolutionPSN07afdf7e-c480-4806-b469-a6a460522bc012
1246319formoterol fumarate 0.01 MG/ML Inhalation SolutionSCD07afdf7e-c480-4806-b469-a6a460522bc012
1246319formoterol fumarate 20 MCG per 2 ML Inhalation SolutionSY07afdf7e-c480-4806-b469-a6a460522bc012
1246319formoterol fumarate 20 MCG/2 ML Inhalation SolutionSY07afdf7e-c480-4806-b469-a6a460522bc012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-655-01623320655012 mL in 1 VIAL2 mlHistorical
62332-655-306233206553030 POUCH in 1 CARTON (62332-655-30) / 1 VIAL in 1 POUCH (62332-655-01) / 2 mL in 1 VIAL30 pouch2021-11-220000-00-00NoNoCurrent
62332-655-606233206556060 POUCH in 1 CARTON (62332-655-60) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL60 pouch2021-11-220000-00-00NoNoCurrent