iopidine 1%

Generic: apraclonidine hydrochloride ophthalmic solution

Labeler: harrow eye, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name iopidine 1%
Generic Name apraclonidine hydrochloride ophthalmic solution
Labeler harrow eye, llc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

apraclonidine hydrochloride 10 mg/mL

Manufacturer
Harrow Eye, LLC

Identifiers & Regulatory

Product NDC 82667-200
Product ID 82667-200_29a937f9-0c0a-1d02-e063-6294a90ace3e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019779
Listing Expiration 2026-12-31
Marketing Start 2023-08-01

Pharmacologic Class

Classes
adrenergic alpha-agonists [moa] alpha-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82667200
Hyphenated Format 82667-200

Supplemental Identifiers

RxCUI
211020 308346
UNII
D2VW67N38H

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name iopidine 1% (source: ndc)
Generic Name apraclonidine hydrochloride ophthalmic solution (source: ndc)
Application Number NDA019779 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 12 POUCH in 1 CARTON (82667-200-01) / 2 VIAL, SINGLE-DOSE in 1 POUCH / .1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

82667-200-01 12 POUCH in 1 CARTON (82667-200-01) / 2 VIAL, SINGLE-DOSE in 1 POUCH / .1 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

apraclonidine hydrochloride (10 mg/mL)

Linked Drug Pages (1)

IOPIDINE 1% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "29a937f9-0c0a-1d02-e063-6294a90ace3e", "openfda": {"unii": ["D2VW67N38H"], "rxcui": ["211020", "308346"], "spl_set_id": ["00f18845-ccde-8678-e063-6294a90a3374"], "manufacturer_name": ["Harrow Eye, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 POUCH in 1 CARTON (82667-200-01)  / 2 VIAL, SINGLE-DOSE in 1 POUCH / .1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "82667-200-01", "marketing_start_date": "20230801"}], "brand_name": "IOPIDINE 1%", "product_id": "82667-200_29a937f9-0c0a-1d02-e063-6294a90ace3e", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "82667-200", "generic_name": "apraclonidine hydrochloride ophthalmic solution", "labeler_name": "Harrow Eye, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "IOPIDINE 1%", "active_ingredients": [{"name": "APRACLONIDINE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "NDA019779", "marketing_category": "NDA", "marketing_start_date": "20230801", "listing_expiration_date": "20261231"}