FDA.reportPublic FDA data

Dulera

Product NDC
78206-127
11-digit product format
782060127
Labeler code
78206
Product ID
78206-127_74079d8a-85a1-4736-8486-76624af02194
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mometasone furoate and formoterol fumarate dihydrate
Dosage form
AEROSOL
Route
RESPIRATORY (INHALATION)
Labeler
Organon LLC
Application
NDA022518
Marketing category
NDA
Marketing start
2021-06-01
Substance
FORMOTEROL FUMARATE; MOMETASONE FUROATE
Active strength
5; 100 ug/1; ug/1
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor 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
Dulera
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FORMOTEROL FUMARATE5 ug/1
MOMETASONE FUROATE100 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii04201GDN4R, W34SHF8J2K
Rxcui1246308, 1246310, 1246311, 1246313, 1660933, 1660934, 1660937, 1660938, 2196590, 2196592

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
624001e0-0eba-4aac-a60c-c2ecb37d4f08Product name120220927
7d8c8d5a-f174-4e6b-97b1-6fd615c5df9aProduct name120210204
1cbe9071-502b-482d-9c24-839b43446576Product name120200123
58f15a44-d9d2-4d61-a39d-7f0223302a8fProduct name120190702
ce567bde-218c-2386-f79b-42addb0c34fbProduct name220180829
1e8b10fc-5c6a-4af6-9363-4bda9402a4f4Product name120180209
fa8c1c3a-f36c-46b1-b4f1-4e877f3dcb1dProduct name220170613
ce066c73-ca6f-49fc-83d4-d3cf6728e8a1Product name120160616
511188c3-b8c1-4966-aa31-5463cfd4fa48Product name120141222
6dcdf27c-6d6a-2465-ccae-faeb308e8070Product name120140508
aca60174-7f12-2753-ec74-0eb827cf0776Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78206-127-01Dulera1 in 1 CARTONAEROSOL17
78206-127-01Dulera120 in 1 CANISTERAEROSOL1207
78206-127-02Dulera60 in 1 CANISTERAEROSOL607
78206-127-02Dulera1 in 1 CARTONAEROSOL17
78206-127-59Dulera1 in 1 CARTONAEROSOL17
78206-127-59Dulera60 in 1 CANISTERAEROSOL607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
78206-127-01GM - Gram78206-1275e552e30-82fb-4a96-a837-9964b8908c9a12021-10-08
78206-127-02GM - Gram78206-1274e2a7e9c-a6ee-4695-8a78-557fea24889f12021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78206-127DULERA (MOMETASONE FUROATE AND FORMOTEROL FUMARATE DIHYDRATE) AEROSOL [ORGANON LLC]5Current NDC, Legacy NDC, 6 package rows20250210_8f399784-f257-4f31-b3dc-368bf2a1864d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1246310Dulera 100/5 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSN8f399784-f257-4f31-b3dc-368bf2a1864d7
1660934Dulera 100/5 MCG/INHAL Metered Dose Inhaler, 60 ActuationsPSN8f399784-f257-4f31-b3dc-368bf2a1864d7
1246313Dulera 200/5 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSN8f399784-f257-4f31-b3dc-368bf2a1864d7
1660938Dulera 200/5 MCG/INHAL Metered Dose Inhaler, 60 ActuationsPSN8f399784-f257-4f31-b3dc-368bf2a1864d7
2196592Dulera 50/5 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSN8f399784-f257-4f31-b3dc-368bf2a1864d7
1246308mometasone furoate/formoterol fumarate 100/5 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSN8f399784-f257-4f31-b3dc-368bf2a1864d7
1660933mometasone furoate/formoterol fumarate 100/5 MCG/INHAL Metered Dose Inhaler, 60 ActuationsPSN8f399784-f257-4f31-b3dc-368bf2a1864d7
1246311mometasone furoate/formoterol fumarate 200/5 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSN8f399784-f257-4f31-b3dc-368bf2a1864d7
1660937mometasone furoate/formoterol fumarate 200/5 MCG/INHAL Metered Dose Inhaler, 60 ActuationsPSN8f399784-f257-4f31-b3dc-368bf2a1864d7
2196590mometasone furoate/formoterol fumarate 50/5 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSN8f399784-f257-4f31-b3dc-368bf2a1864d7
2196592120 ACTUAT formoterol fumarate 0.005 MG/ACTUAT / mometasone furoate 0.05 MG/ACTUAT Metered Dose Inhaler [Dulera]SBD8f399784-f257-4f31-b3dc-368bf2a1864d7
1246310120 ACTUAT formoterol fumarate 0.005 MG/ACTUAT / mometasone furoate 0.1 MG/ACTUAT Metered Dose Inhaler [Dulera]SBD8f399784-f257-4f31-b3dc-368bf2a1864d7
1246313120 ACTUAT formoterol fumarate 0.005 MG/ACTUAT / mometasone furoate 0.2 MG/ACTUAT Metered Dose Inhaler [Dulera]SBD8f399784-f257-4f31-b3dc-368bf2a1864d7
166093460 ACTUAT formoterol fumarate 0.005 MG/ACTUAT / mometasone furoate 0.1 MG/ACTUAT Metered Dose Inhaler [Dulera]SBD8f399784-f257-4f31-b3dc-368bf2a1864d7
166093860 ACTUAT formoterol fumarate 0.005 MG/ACTUAT / mometasone furoate 0.2 MG/ACTUAT Metered Dose Inhaler [Dulera]SBD8f399784-f257-4f31-b3dc-368bf2a1864d7
2196590120 ACTUAT formoterol fumarate 0.005 MG/ACTUAT / mometasone furoate 0.05 MG/ACTUAT Metered Dose InhalerSCD8f399784-f257-4f31-b3dc-368bf2a1864d7
1246308120 ACTUAT formoterol fumarate 0.005 MG/ACTUAT / mometasone furoate 0.1 MG/ACTUAT Metered Dose InhalerSCD8f399784-f257-4f31-b3dc-368bf2a1864d7
1246311120 ACTUAT formoterol fumarate 0.005 MG/ACTUAT / mometasone furoate 0.2 MG/ACTUAT Metered Dose InhalerSCD8f399784-f257-4f31-b3dc-368bf2a1864d7
166093360 ACTUAT formoterol fumarate 0.005 MG/ACTUAT / mometasone furoate 0.1 MG/ACTUAT Metered Dose InhalerSCD8f399784-f257-4f31-b3dc-368bf2a1864d7
166093760 ACTUAT formoterol fumarate 0.005 MG/ACTUAT / mometasone furoate 0.2 MG/ACTUAT Metered Dose InhalerSCD8f399784-f257-4f31-b3dc-368bf2a1864d7
1246310Dulera (mometasone furoate 100 MCG / formoterol fumarate 5 MCG) per ACTUAT Inhalation Aerosol, 120 ACTUATSY8f399784-f257-4f31-b3dc-368bf2a1864d7
1660934Dulera (mometasone furoate 100 MCG / formoterol fumarate 5 MCG) per ACTUAT Inhalation Aerosol, 60 ACTUATSY8f399784-f257-4f31-b3dc-368bf2a1864d7
1246313Dulera (mometasone furoate 200 MCG / formoterol fumarate 5 MCG) per ACTUAT Inhalation Aerosol, 120 ACTUATSY8f399784-f257-4f31-b3dc-368bf2a1864d7
1660938Dulera (mometasone furoate 200 MCG / formoterol fumarate 5 MCG) per ACTUAT Inhalation Aerosol, 60 ACTUATSY8f399784-f257-4f31-b3dc-368bf2a1864d7
2196592Dulera (mometasone furoate 50 MCG / formoterol fumarate 5 MCG) per ACTUAT Inhalation Aerosol, 120 ACTUATSY8f399784-f257-4f31-b3dc-368bf2a1864d7
1246310Dulera 100 mcg/5 mcg per ACTUAT Metered Dose Inhaler, 120 ACTUATSY8f399784-f257-4f31-b3dc-368bf2a1864d7
1660934Dulera 100 mcg/5 mcg per ACTUAT Metered Dose Inhaler, 60 ACTUATSY8f399784-f257-4f31-b3dc-368bf2a1864d7
1246310Dulera 100/5 Metered Dose Inhaler, 120 ACTUATSY8f399784-f257-4f31-b3dc-368bf2a1864d7
1660934Dulera 100/5 Metered Dose Inhaler, 60 ACTUATSY8f399784-f257-4f31-b3dc-368bf2a1864d7
1246313Dulera 200 mcg/5 mcg per ACTUAT Metered Dose Inhaler, 120 ACTUATSY8f399784-f257-4f31-b3dc-368bf2a1864d7
1660938Dulera 200 mcg/5 mcg per ACTUAT Metered Dose Inhaler, 60 ACTUATSY8f399784-f257-4f31-b3dc-368bf2a1864d7
1246313Dulera 200/5 Metered Dose Inhaler, 120 ACTUATSY8f399784-f257-4f31-b3dc-368bf2a1864d7
1660938Dulera 200/5 Metered Dose Inhaler, 60 ACTUATSY8f399784-f257-4f31-b3dc-368bf2a1864d7
2196592Dulera 50 mcg/5 mcg per ACTUAT Metered Dose Inhaler, 120 ACTUATSY8f399784-f257-4f31-b3dc-368bf2a1864d7
2196592Dulera 50/5 Metered Dose Inhaler, 120 ACTUATSY8f399784-f257-4f31-b3dc-368bf2a1864d7
1246308formoterol fumarate 0.005 MG / mometasone furoate 0.1 MG per ACTUAT Metered Dose Inhaler, 120 ACTUATSY8f399784-f257-4f31-b3dc-368bf2a1864d7
1660933formoterol fumarate 0.005 MG / mometasone furoate 0.1 MG per ACTUAT Metered Dose Inhaler, 60 ACTUATSY8f399784-f257-4f31-b3dc-368bf2a1864d7
1246311formoterol fumarate 0.005 MG / mometasone furoate 0.2 MG per ACTUAT Metered Dose Inhaler, 120 ACTUATSY8f399784-f257-4f31-b3dc-368bf2a1864d7
1660937formoterol fumarate 0.005 MG / mometasone furoate 0.2 MG per ACTUAT Metered Dose Inhaler, 60 ACTUATSY8f399784-f257-4f31-b3dc-368bf2a1864d7
1246308formoterol fumarate 5 MCG / mometasone furoate 100 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUATSY8f399784-f257-4f31-b3dc-368bf2a1864d7
1660933formoterol fumarate 5 MCG / mometasone furoate 100 MCG per ACTUAT Metered Dose Inhaler, 60 ACTUATSY8f399784-f257-4f31-b3dc-368bf2a1864d7
1246311formoterol fumarate 5 MCG / mometasone furoate 200 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUATSY8f399784-f257-4f31-b3dc-368bf2a1864d7
1660937formoterol fumarate 5 MCG / mometasone furoate 200 MCG per ACTUAT Metered Dose Inhaler, 60 ACTUATSY8f399784-f257-4f31-b3dc-368bf2a1864d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78206-127-01782060127011 CANISTER in 1 CARTON (78206-127-01) / 120 AEROSOL in 1 CANISTER1 canister2021-06-010000-00-00NoNoCurrent
78206-127-02782060127021 CANISTER in 1 CARTON (78206-127-02) / 60 AEROSOL in 1 CANISTER1 canister2021-06-010000-00-00NoNoCurrent
78206-127-59782060127591 CANISTER in 1 CARTON (78206-127-59) / 60 AEROSOL in 1 CANISTER1 canister2021-06-010000-00-00NoNoCurrent