FDA.reportPublic FDA data

Budesonide and Formoterol Fumarate Dihydrate

Product NDC
85766-113
11-digit product format
857660113
Labeler code
85766
Product ID
85766-113_50320ede-02f9-0227-e063-6294a90a5e2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Budesonide and Formoterol Fumarate Dihydrate
Dosage form
AEROSOL
Route
RESPIRATORY (INHALATION)
Labeler
Sportpharm LLC
Application
NDA021929
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-01-03
Substance
BUDESONIDE; FORMOTEROL FUMARATE
Active strength
80; 4.5 ug/1; ug/1
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Budesonide and Formoterol Fumarate Dihydrate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUDESONIDE80 ug/1
FORMOTEROL FUMARATE4.5 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW34SHF8J2K, Q3OKS62Q6X
Rxcui1246288, 1246304

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0c06c4f4-ea2d-4e6a-a22a-0cf292716367Product name420250303
7816cdf6-b925-4282-bedd-11ae25d518a1Product name120250116
d17a61d0-e77b-4bcb-ad22-343ff1a3ef4dProduct name220240424
9ab9f611-cedd-47ea-a83c-0489c8c04fc6Product name120231006
c76bcd0f-25eb-471e-b970-1956c95c26c5Product name120230425
a03aea00-1d8b-bfad-a82e-f52f68676f63Product name220221216
54a29484-7dde-4771-9547-005149321621Product name120220720
793b53dd-c0ea-da17-9ac0-fb5c4a6e0743Product name520211018
218c043e-94e5-4e66-a363-d0d446485bc6Product name220210512
7d8c8d5a-f174-4e6b-97b1-6fd615c5df9aProduct name120210204
5e2e25b6-cb6b-8e81-afe3-62c3e2cd56c7Product name920210127
1cbe9071-502b-482d-9c24-839b43446576Product name120200123
da63bc8c-2e89-4044-89d6-1facbff5474eProduct name120200121
58f15a44-d9d2-4d61-a39d-7f0223302a8fProduct name120190702
ce066c73-ca6f-49fc-83d4-d3cf6728e8a1Product name120160616
899766bc-33ce-8154-910d-12cb0889fb56Product name220150106

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85766-113-12Budesonide and Formoterol Fumarate Dihydrate1 in 1 CARTONAEROSOL13
85766-113-12Budesonide and Formoterol Fumarate Dihydrate1 in 1 POUCHAEROSOL13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1246304budesonide/formoterol fumarate 160/4.5 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSNd6cc66c9-6f97-4ea8-a787-30a048004c773
1246288budesonide/formoterol fumarate 80/4.5 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSNd6cc66c9-6f97-4ea8-a787-30a048004c773
1246288120 ACTUAT budesonide 0.08 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose InhalerSCDd6cc66c9-6f97-4ea8-a787-30a048004c773
1246304120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose InhalerSCDd6cc66c9-6f97-4ea8-a787-30a048004c773
1246288budesonide 0.08 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 120 ACTUATSYd6cc66c9-6f97-4ea8-a787-30a048004c773
1246304budesonide 0.16 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 120 ACTUATSYd6cc66c9-6f97-4ea8-a787-30a048004c773
1246304budesonide 160 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUATSYd6cc66c9-6f97-4ea8-a787-30a048004c773
1246288budesonide 80 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUATSYd6cc66c9-6f97-4ea8-a787-30a048004c773

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85766-113-12857660113121 POUCH in 1 CARTON (85766-113-12) / 1 CANISTER in 1 POUCH / 120 AEROSOL in 1 CANISTER1 pouch2025-10-31NoNoHistorical