NDC 62332-506

Azelastine Hydrochloride Ophthalmic Solution 0.05%

Azelastine Hydrochloride Ophthalmic Solution 0.05%

Azelastine Hydrochloride Ophthalmic Solution 0.05% is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Alembic Pharmaceuticals Inc.. The primary component is Azelastine Hydrochloride.

• Product ID: 62332-506_104eaae7-b5b9-4a4a-96fc-88bc9ba2bf5c
• NDC: 62332-506
• Product Type: Human Prescription Drug
• Proprietary Name: Azelastine Hydrochloride Ophthalmic Solution 0.05%
• Generic Name: Azelastine Hydrochloride Ophthalmic Solution 0.05%
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2019-03-20
• Marketing Category: ANDA / ANDA
• Application Number: ANDA209620
• Labeler Name: Alembic Pharmaceuticals Inc.
• Substance Name: AZELASTINE HYDROCHLORIDE
• Active Ingredient Strength: 1 mg/mL
• Pharm Classes: Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 62332-506-06

1 BOTTLE in 1 CARTON (62332-506-06) > 6 mL in 1 BOTTLE

• Marketing Start Date: 2019-03-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 62332-506-06 [62332050606]

Azelastine Hydrochloride Ophthalmic Solution 0.05% SOLUTION/ DROPS

• Marketing Category: ANDA
• Application Number: ANDA209620
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-03-20

Drug Details

Active Ingredients

Ingredient	Strength
AZELASTINE HYDROCHLORIDE	.5 mg/mL

OpenFDA Data

• SPL SET ID: 7532ed82-5cfa-49da-83e5-c57ffdd3adbb
• Manufacturer:
  • Alembic Pharmaceuticals Inc.
• UNII:
  • 0L591QR10I
• RxNorm Concept Unique ID - RxCUI:
  • 860805
• UPC Code:
  • 0362332506064

Pharmacological Class

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