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United States · US · US:84226-100_485ee479-310b-1721-e063-6394a90aed7d

VIZZ

Orange BookUNIISPLATC S01EB08

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

Identification

ManufacturerLENZ Therapeutics, Inc.
CountryUS (United States)
ATC codeS01EB08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    8422610011
    5 POUCH in 1 CARTON (84226-100-11) / 5 AMPULE in 1 POUCH (84226-100-01) / .4 mL in 1 AMPULE
  • ndc11
    8422610021
    5 POUCH in 1 CARTON (84226-100-21) / 5 AMPULE in 1 POUCH (84226-100-02) / .25 mL in 1 AMPULE

Annotations

UNII (FDA Substance ID)
3B22O325Q6
ACECLIDINE HYDROCHLORIDE
Orange Book
N218585
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "3B22O325Q6",
    "rxcui": null,
    "inchikey": "LWWSARSTZGNKGV-UHFFFAOYSA-N",
    "display_name": "ACECLIDINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "7aed8024-ad30-44d6-8f3b-63338ad3ce52": {
      "match": "brand_token",
      "title": "VIZZ (ACECLIDINE) SOLUTION/ DROPS [LENZ THERAPEUTICS, INC.]",
      "spl_version": "6",
      "published_date": "2026-01-16"
    }
  },
  "productid": "84226-100_485ee479-310b-1721-e063-6394a90aed7d",
  "productndc": "84226-100",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "218585",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1.44% BASE",
        "product_no": "001",
        "approval_date": "Jul 31, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACECLIDINE HYDROCHLORIDE",
  "proprietary_name": "VIZZ",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA218585",
  "marketing_category": "NDA",
  "nonproprietary_name": "Aceclidine",
  "start_marketing_date": "20250731",
  "active_numerator_strength": "14.66"
}

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