NDC 0037-0245

DYMISTA

Azelastine Hydrochloride And Fluticasone Propionate

DYMISTA is a Nasal Spray, Metered in the Human Prescription Drug category. It is labeled and distributed by Meda Pharmaceuticals. The primary component is Azelastine Hydrochloride; Fluticasone Propionate.

• Product ID: 0037-0245_15e0ecb9-212f-41b4-aee5-0dc15da272f0
• NDC: 0037-0245
• Product Type: Human Prescription Drug
• Proprietary Name: DYMISTA
• Generic Name: Azelastine Hydrochloride And Fluticasone Propionate
• Dosage Form: Spray, Metered
• Route of Administration: NASAL
• Marketing Start Date: 2012-05-01
• Marketing Category: NDA / NDA
• Application Number: NDA202236
• Labeler Name: Meda Pharmaceuticals
• Substance Name: AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE
• Active Ingredient Strength: 137 ug/1; ug/1
• Pharm Classes: Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0037-0245-06

1 BOTTLE, SPRAY in 1 BOX (0037-0245-06) > 28 SPRAY, METERED in 1 BOTTLE, SPRAY

• Marketing Start Date: 2012-05-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0037-0245-06 [00037024506]

DYMISTA SPRAY, METERED

• Marketing Category: NDA
• Application Number: NDA202236
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-05-01

NDC 0037-0245-23 [00037024523]

DYMISTA SPRAY, METERED

• Marketing Category: NDA
• Application Number: NDA202236
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2012-05-01

Drug Details

Active Ingredients

Ingredient	Strength
AZELASTINE HYDROCHLORIDE	137 ug/1

OpenFDA Data

• SPL SET ID: 4c557ec4-c4cf-11df-851a-0800200c9a66
• Manufacturer:
  • Meda Pharmaceuticals
• UNII:
  • 0L591QR10I
  • O2GMZ0LF5W
• RxNorm Concept Unique ID - RxCUI:
  • 1797849
  • 1797847

Pharmacological Class

• Histamine H1 Receptor Antagonists [MoA]
• Histamine-1 Receptor Antagonist [EPC]
• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]

NDC Crossover Matching brand name "DYMISTA" or generic name "Azelastine Hydrochloride And Fluticasone Propionate"

NDC	Brand Name	Generic Name
0037-0245	DYMISTA	Azelastine Hydrochloride and Fluticasone Propionate
0378-3458	Azelastine Hydrochloride and Fluticasone Propionate	Azelastine Hydrochloride and Fluticasone Propionate
60505-0953	Azelastine hydrochloride and Fluticasone propionate	Azelastine hydrochloride and Fluticasone propionate
69621-812	Ticalast	azelastine hydrochloride and fluticasone propionate