dulera

Generic: mometasone furoate and formoterol fumarate dihydrate

Labeler: organon llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name dulera
Generic Name mometasone furoate and formoterol fumarate dihydrate
Labeler organon llc
Dosage Form AEROSOL
Routes
RESPIRATORY (INHALATION)
Active Ingredients

formoterol fumarate 5 ug/1, mometasone furoate 200 ug/1

Manufacturer
Organon LLC

Identifiers & Regulatory

Product NDC 78206-126
Product ID 78206-126_74079d8a-85a1-4736-8486-76624af02194
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022518
Listing Expiration 2027-12-31
Marketing Start 2021-06-01

Pharmacologic Class

Classes
adrenergic beta2-agonists [moa] corticosteroid hormone receptor agonists [moa] corticosteroid [epc] beta2-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 78206126
Hyphenated Format 78206-126

Supplemental Identifiers

RxCUI
1246308 1246310 1246311 1246313 1660933 1660934 1660937 1660938 2196590 2196592
UNII
04201GDN4R W34SHF8J2K

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name dulera (source: ndc)
Generic Name mometasone furoate and formoterol fumarate dihydrate (source: ndc)
Application Number NDA022518 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 5 ug/1
  • 200 ug/1
source: ndc
Packaging
  • 1 CANISTER in 1 CARTON (78206-126-01) / 120 AEROSOL in 1 CANISTER
  • 1 CANISTER in 1 CARTON (78206-126-02) / 60 AEROSOL in 1 CANISTER
  • 1 CANISTER in 1 CARTON (78206-126-59) / 60 AEROSOL in 1 CANISTER
source: ndc

Packages (3)

78206-126-01 1 CANISTER in 1 CARTON (78206-126-01) / 120 AEROSOL in 1 CANISTER 78206-126-02 1 CANISTER in 1 CARTON (78206-126-02) / 60 AEROSOL in 1 CANISTER 78206-126-59 1 CANISTER in 1 CARTON (78206-126-59) / 60 AEROSOL in 1 CANISTER

Ingredients (2)

formoterol fumarate (5 ug/1) mometasone furoate (200 ug/1)

Linked Drug Pages (1)

Dulera ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "74079d8a-85a1-4736-8486-76624af02194", "openfda": {"unii": ["04201GDN4R", "W34SHF8J2K"], "rxcui": ["1246308", "1246310", "1246311", "1246313", "1660933", "1660934", "1660937", "1660938", "2196590", "2196592"], "spl_set_id": ["8f399784-f257-4f31-b3dc-368bf2a1864d"], "manufacturer_name": ["Organon LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CANISTER in 1 CARTON (78206-126-01)  / 120 AEROSOL in 1 CANISTER", "package_ndc": "78206-126-01", "marketing_start_date": "20210601"}, {"sample": false, "description": "1 CANISTER in 1 CARTON (78206-126-02)  / 60 AEROSOL in 1 CANISTER", "package_ndc": "78206-126-02", "marketing_start_date": "20210601"}, {"sample": false, "description": "1 CANISTER in 1 CARTON (78206-126-59)  / 60 AEROSOL in 1 CANISTER", "package_ndc": "78206-126-59", "marketing_start_date": "20210601"}], "brand_name": "Dulera", "product_id": "78206-126_74079d8a-85a1-4736-8486-76624af02194", "dosage_form": "AEROSOL", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "78206-126", "generic_name": "mometasone furoate and formoterol fumarate dihydrate", "labeler_name": "Organon LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dulera", "active_ingredients": [{"name": "FORMOTEROL FUMARATE", "strength": "5 ug/1"}, {"name": "MOMETASONE FUROATE", "strength": "200 ug/1"}], "application_number": "NDA022518", "marketing_category": "NDA", "marketing_start_date": "20210601", "listing_expiration_date": "20271231"}