NDC 50090-1916

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 A-s Medication Solutions. The primary component is Mometasone Furoate; Formoterol Fumarate.

• Product ID: 50090-1916_47947df3-74d8-4025-a353-59321104147a
• NDC: 50090-1916
• 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: 2010-06-22
• Marketing Category: NDA / NDA
• Application Number: NDA022518
• Labeler Name: A-S Medication Solutions
• Substance Name: MOMETASONE FUROATE; FORMOTEROL FUMARATE
• Active Ingredient Strength: 200 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: 2019-12-31

Packaging

NDC 50090-1916-0

1 CANISTER in 1 CARTON (50090-1916-0) > 60 AEROSOL in 1 CANISTER

• Marketing Start Date: 2015-07-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50090-1916-0 [50090191600]

Dulera AEROSOL

• Marketing Category: NDA
• Application Number: NDA022518
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2015-07-06
• Marketing End Date: 2018-09-30

Drug Details

Active Ingredients

Ingredient	Strength
MOMETASONE FUROATE	200 ug/1

OpenFDA Data

• SPL SET ID: 56ca7ab1-28ec-49b2-8b17-4c11100e67c6
• Manufacturer:
  • A-S Medication Solutions
• UNII:
  • 04201GDN4R
  • W34SHF8J2K
• RxNorm Concept Unique ID - RxCUI:
  • 1660937
  • 1660938

Pharmacological Class

• 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