NDC 67877-477

Azelastine

Azelastine

Azelastine is a Nasal Spray, Metered in the Human Prescription Drug category. It is labeled and distributed by Ascend Laboratories, Llc. The primary component is Azelastine Hydrochloride.

• Product ID: 67877-477_62d8b6b6-b78e-4c50-a630-837c15de22c0
• NDC: 67877-477
• Product Type: Human Prescription Drug
• Proprietary Name: Azelastine
• Generic Name: Azelastine
• Dosage Form: Spray, Metered
• Route of Administration: NASAL
• Marketing Start Date: 2017-08-18
• Marketing Category: ANDA / ANDA
• Application Number: ANDA208156
• Labeler Name: Ascend Laboratories, LLC
• Substance Name: AZELASTINE HYDROCHLORIDE
• Active Ingredient Strength: 137 ug/1
• Pharm Classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 67877-477-50

1 SPRAY, METERED in 1 BOTTLE (67877-477-50)

• Marketing Start Date: 2017-08-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67877-477-50 [67877047750]

Azelastine SPRAY, METERED

• Marketing Category: ANDA
• Application Number: ANDA208156
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-08-18

Drug Details

Active Ingredients

Ingredient	Strength
AZELASTINE HYDROCHLORIDE	137 ug/1

OpenFDA Data

• SPL SET ID: 77b20c6b-f30f-42a9-a0ef-d5d0bd3feb56
• Manufacturer:
  • Ascend Laboratories, LLC
• UNII:
  • 0L591QR10I
• RxNorm Concept Unique ID - RxCUI:
  • 1797867
• UPC Code:
  • 0367877477503

Pharmacological Class

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

Medicade Reported Pricing

67877047750 AZELASTINE 0.1% (137 MCG) SPRY

Pricing Unit: ML | Drug Type:

NDC Crossover Matching brand name "Azelastine" or generic name "Azelastine"

NDC	Brand Name	Generic Name
67877-477	Azelastine	Azelastine
42291-094	Azelastine Hydrochloride	Azelastine
50090-3833	Azelastine Hydrochloride	Azelastine
65162-676	Azelastine Hydrochloride	Azelastine