NDC 0065-0660

IOPIDINE

Apraclonidine Hydrochloride

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

• Product ID: 0065-0660_1476ec41-31c3-4848-9bfd-8899fa302fc2
• NDC: 0065-0660
• Product Type: Human Prescription Drug
• Proprietary Name: IOPIDINE
• Generic Name: Apraclonidine Hydrochloride
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 1988-05-15
• Marketing Category: NDA / NDA
• Application Number: NDA019779
• Labeler Name: Alcon Laboratories, Inc.
• Substance Name: APRACLONIDINE HYDROCHLORIDE
• Active Ingredient Strength: 10 mg/mL
• Pharm Classes: Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0065-0660-10

12 POUCH in 1 CARTON (0065-0660-10) > 2 VIAL, SINGLE-USE in 1 POUCH > .1 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 1988-05-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0065-0660-10 [00065066010]

IOPIDINE SOLUTION/ DROPS

• Marketing Category: NDA
• Application Number: NDA019779
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1988-05-15

Drug Details

Active Ingredients

Ingredient	Strength
APRACLONIDINE HYDROCHLORIDE	10 mg/mL

OpenFDA Data

• SPL SET ID: 2a6c44a6-e415-467f-bf3b-3e7f2c7dc714
• Manufacturer:
  • Alcon Laboratories, Inc.
• UNII:
  • D2VW67N38H
• RxNorm Concept Unique ID - RxCUI:
  • 211020
  • 308346

Pharmacological Class

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

NDC Crossover Matching brand name "IOPIDINE" or generic name "Apraclonidine Hydrochloride"

NDC	Brand Name	Generic Name
0065-0660	IOPIDINE	apraclonidine hydrochloride
0065-0665	Iopidine	apraclonidine
17478-716	Apraclonidine Ophthalmic	Apraclonidine Hydrochloride