NDC 0065-0665

Iopidine

Apraclonidine

Iopidine is a Ophthalmic Solution in the Human Prescription Drug category. It is labeled and distributed by Alcon Laboratories, Inc.. The primary component is Apraclonidine Hydrochloride.

• Product ID: 0065-0665_474ad610-8b43-4cff-b4a7-96977f25c26b
• NDC: 0065-0665
• Product Type: Human Prescription Drug
• Proprietary Name: Iopidine
• Generic Name: Apraclonidine
• Dosage Form: Solution
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 1993-10-01
• Marketing Category: NDA / NDA
• Application Number: NDA020258
• Labeler Name: Alcon Laboratories, Inc.
• Substance Name: APRACLONIDINE HYDROCHLORIDE
• Active Ingredient Strength: 5 mg/mL
• Pharm Classes: Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0065-0665-10

10 mL in 1 BOTTLE (0065-0665-10)

• Marketing Start Date: 1993-10-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0065-0665-10 [00065066510]

Iopidine SOLUTION

• Marketing Category: NDA
• Application Number: NDA020258
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1993-10-01

NDC 0065-0665-05 [00065066505]

Iopidine SOLUTION

• Marketing Category: NDA
• Application Number: NDA020258
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1993-10-01

Drug Details

Active Ingredients

Ingredient	Strength
APRACLONIDINE HYDROCHLORIDE	5 mg/mL

OpenFDA Data

• SPL SET ID: de798d0d-a93c-40fb-95ea-10a4e6b287b7
• Manufacturer:
  • Alcon Laboratories, Inc.
• UNII:
  • D2VW67N38H
• RxNorm Concept Unique ID - RxCUI:
  • 108896
  • 308345
• UPC Code:
  • 0300650665056

Pharmacological Class

• Adrenergic alpha-Agonists [MoA]
• alpha-Adrenergic Agonist [EPC]

NDC Crossover Matching brand name "Iopidine" or generic name "Apraclonidine"

NDC	Brand Name	Generic Name
0065-0660	IOPIDINE	apraclonidine hydrochloride
0065-0665	Iopidine	apraclonidine
61314-665	Apraclonidine	Apraclonidine