timolol maleate ophthalmic gel forming solution

Orange BookUNIISPLATC C07AA06

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerGland Pharma Limited

CountryUS (United States)

ATC codeC07AA06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6808345801
1 BOTTLE in 1 CARTON (68083-458-01) / 5 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

P8Y54F701R

TIMOLOL MALEATE

RxCUI 42933

Orange Book

A214645

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "P8Y54F701R",
    "rxcui": "42933",
    "inchikey": "WLRMANUAADYWEA-NWASOUNVSA-N",
    "display_name": "TIMOLOL MALEATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "e16c33fd-aa86-49ad-a767-c79ade4a62c7": {
      "match": "brand_token",
      "title": "TIMOLOL MALEATE SOLUTION/ DROPS [PACIFIC PHARMA, INC.]",
      "spl_version": "16",
      "published_date": "2026-05-25"
    }
  },
  "productid": "68083-458_0c73f98d-4f49-415a-abc5-2d253061e669",
  "productndc": "68083-458",
  "dosage_form": "SOLUTION, GEL FORMING / DROPS",
  "orange_book": {
    "appl_no": "214645",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 0.25% BASE",
        "product_no": "001",
        "approval_date": "Jun 24, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 0.5% BASE",
        "product_no": "002",
        "approval_date": "Feb 14, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TIMOLOL MALEATE",
  "proprietary_name": "timolol maleate ophthalmic gel forming solution",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA214645",
  "marketing_category": "ANDA",
  "nonproprietary_name": "timolol maleate ophthalmic gel forming",
  "start_marketing_date": "20230214",
  "active_numerator_strength": "5"
}

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