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United States · US · US:82667-300_4dc9b9f7-e722-51ce-e063-6394a90a5219

IHEEZO

Orange BookUNIISPLATC S01HA08

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerHarrow Eye, LLC
CountryUS (United States)
ATC codeS01HA08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    8266730000
    1 POUCH in 1 CARTON (82667-300-00) / 1 VIAL in 1 POUCH / 800 mg in 1 VIAL
  • ndc11
    8266730001
    1 POUCH in 1 CARTON (82667-300-01) / 1 VIAL in 1 POUCH / 800 mg in 1 VIAL
  • ndc11
    8266730005
    5 POUCH in 1 CARTON (82667-300-05) / 1 VIAL in 1 POUCH / 800 mg in 1 VIAL

Annotations

UNII (FDA Substance ID)
LT7Z1YW11H
CHLOROPROCAINE HYDROCHLORIDE
RxCUI 53616
Orange Book
N216227
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "LT7Z1YW11H",
    "rxcui": "53616",
    "inchikey": "SZKQYDBPUCZLRX-UHFFFAOYSA-N",
    "display_name": "CHLOROPROCAINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "ea3b2d2c-8b33-d199-e053-2995a90a699c": {
      "match": "brand_token",
      "title": "IHEEZO (CHLOROPROCAINE HYDROCHLORIDE OPHTHALMIC GEL) GEL [HARROW EYE, LLC]",
      "spl_version": "4",
      "published_date": "2026-03-26"
    }
  },
  "productid": "82667-300_4dc9b9f7-e722-51ce-e063-6394a90a5219",
  "productndc": "82667-300",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "216227",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "3%",
        "product_no": "001",
        "approval_date": "Sep 27, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CHLOROPROCAINE HYDROCHLORIDE",
  "proprietary_name": "IHEEZO",
  "active_ingred_unit": "mg/800mg",
  "application_number": "NDA216227",
  "marketing_category": "NDA",
  "nonproprietary_name": "chloroprocaine hydrochloride ophthalmic gel",
  "start_marketing_date": "20220927",
  "active_numerator_strength": "24"
}

Related drugs

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