FDA.reportPublic FDA data

Formoterol fumarate

Product NDC
63629-8814
11-digit product format
636298814
Labeler code
63629
Product ID
63629-8814_20678b2e-fc63-4809-a890-b2382014c7f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Formoterol fumarate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Bryant Ranch Prepack
Application
ANDA091141
Marketing category
ANDA
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
63629-8814-1Formoterol fumarate60 in 1 CARTONSOLUTION60102
63629-8814-1Formoterol fumarate1 in 1 POUCHSOLUTION1102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8814-1ML - Milliliter63629-881448b9b602-6285-421a-9f4c-5fcfb7b9d6fb12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8814FORMOTEROL FUMARATE SOLUTION [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 2 package rows20240113_d8f7c5ff-bd3c-4eab-b58a-1e3a478e5879.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1246319formoterol fumarate 20 MCG in 2 ML Inhalation SolutionPSNd8f7c5ff-bd3c-4eab-b58a-1e3a478e5879102
1246319formoterol fumarate 0.01 MG/ML Inhalation SolutionSCDd8f7c5ff-bd3c-4eab-b58a-1e3a478e5879102
1246319formoterol fumarate 20 MCG per 2 ML Inhalation SolutionSYd8f7c5ff-bd3c-4eab-b58a-1e3a478e5879102
1246319formoterol fumarate 20 MCG/2 ML Inhalation SolutionSYd8f7c5ff-bd3c-4eab-b58a-1e3a478e5879102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8814-16362988140160 POUCH in 1 CARTON (63629-8814-1) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL60 pouch2021-09-100000-00-00NoNoCurrent