NDC 78206-126

Dulera

Mometasone Furoate And Formoterol Fumarate Dihydrate

Dulera is a Respiratory (inhalation) Aerosol in the Human Prescription Drug category. It is labeled and distributed by Organon Llc. The primary component is Formoterol Fumarate; Mometasone Furoate.

• Product ID: 78206-126_033d28d6-fd11-406a-ad78-09cd64dad41d
• NDC: 78206-126
• Product Type: Human Prescription Drug
• Proprietary Name: Dulera
• Generic Name: Mometasone Furoate And Formoterol Fumarate Dihydrate
• Dosage Form: Aerosol
• Route of Administration: RESPIRATORY (INHALATION)
• Marketing Start Date: 2021-06-01
• Marketing Category: NDA /
• Application Number: NDA022518
• Labeler Name: Organon LLC
• Substance Name: FORMOTEROL FUMARATE; MOMETASONE FUROATE
• Active Ingredient Strength: 5 ug/1; ug/1
• Pharm Classes: Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 78206-126-01

1 CANISTER in 1 CARTON (78206-126-01) > 120 AEROSOL in 1 CANISTER

• Marketing Start Date: 2021-06-01
• NDC Exclude Flag: N
• Sample Package?: N

Drug Details

NDC Crossover Matching brand name "Dulera" or generic name "Mometasone Furoate And Formoterol Fumarate Dihydrate"

NDC	Brand Name	Generic Name
0085-2223	Dulera	mometasone furoate and formoterol fumarate dihydrate
0085-4610	Dulera	mometasone furoate and formoterol fumarate dihydrate
0085-7206	Dulera	mometasone furoate and formoterol fumarate dihydrate
50090-1916	Dulera	mometasone furoate and formoterol fumarate dihydrate
78206-125	Dulera	mometasone furoate and formoterol fumarate dihydrate
78206-126	Dulera	mometasone furoate and formoterol fumarate dihydrate
78206-127	Dulera	mometasone furoate and formoterol fumarate dihydrate