NDC 0085-2223

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 Merck Sharp & Dohme Corp.. The primary component is Mometasone Furoate; Formoterol Fumarate.

• Product ID: 0085-2223_04037d69-9f54-40cb-82be-0435ac135c01
• NDC: 0085-2223
• 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: 2019-08-12
• Marketing Category: NDA / NDA
• Application Number: NDA022518
• Labeler Name: Merck Sharp & Dohme Corp.
• Substance Name: MOMETASONE FUROATE; FORMOTEROL FUMARATE
• Active Ingredient Strength: 50 ug/1; ug/1
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0085-2223-01

1 CANISTER in 1 CARTON (0085-2223-01) > 120 AEROSOL in 1 CANISTER

• Marketing Start Date: 2019-08-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0085-2223-02 [00085222302]

Dulera AEROSOL

• Marketing Category: NDA
• Application Number: NDA022518
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-08-12

NDC 0085-2223-01 [00085222301]

Dulera AEROSOL

• Marketing Category: NDA
• Application Number: NDA022518
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2019-08-12

Drug Details

Active Ingredients

Ingredient	Strength
MOMETASONE FUROATE	50 ug/1

OpenFDA Data

• SPL SET ID: 116464ce-cfd8-4b9f-8b5a-3a114b6ff2b1
• Manufacturer:
  • Merck Sharp & Dohme Corp.
• UNII:
  • 04201GDN4R
  • W34SHF8J2K
• RxNorm Concept Unique ID - RxCUI:
  • 2196592
  • 2196590
  • 1660937
  • 1660934
  • 1246308
  • 1246313
  • 1246310
  • 1246311
  • 1660938
  • 1660933

Pharmacological Class

• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]
• Adrenergic beta2-Agonists [MoA]
• beta2-Adrenergic Agonist [EPC]
• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]
• Corticosteroid Hormone Receptor Agonists [MoA]
• Adrenergic beta2-Agonists [MoA]
• beta2-Adrenergic Agonist [EPC]

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