FDA.reportPublic FDA data

Formoterol fumarate

Product NDC
63629-8813
11-digit product format
636298813
Labeler code
63629
Product ID
63629-8813_37f67ff0-5292-47b4-849e-25cf51d1d61b
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
63629-8813-1Formoterol fumarate1 in 1 POUCHSOLUTION1102
63629-8813-1Formoterol fumarate30 in 1 CARTONSOLUTION30102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8813-1ML - Milliliter63629-8813535a6ae8-fc94-4d6b-8827-cfbdc6c3e18f12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8813FORMOTEROL FUMARATE SOLUTION [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 2 package rows20240113_9786f3e2-4265-4246-9999-f73cd6b33fc8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1246319formoterol fumarate 20 MCG in 2 ML Inhalation SolutionPSN9786f3e2-4265-4246-9999-f73cd6b33fc8102
1246319formoterol fumarate 0.01 MG/ML Inhalation SolutionSCD9786f3e2-4265-4246-9999-f73cd6b33fc8102
1246319formoterol fumarate 20 MCG per 2 ML Inhalation SolutionSY9786f3e2-4265-4246-9999-f73cd6b33fc8102
1246319formoterol fumarate 20 MCG/2 ML Inhalation SolutionSY9786f3e2-4265-4246-9999-f73cd6b33fc8102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8813-16362988130130 POUCH in 1 CARTON (63629-8813-1) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL30 pouch2021-09-100000-00-00NoNoCurrent