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United States · US · US:61314-224_ba538348-67cf-4031-84e5-cb84647af104

Timolol GFS

Orange BookUNIISPLATC C07AA06

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

Identification

ManufacturerSandoz Inc
CountryUS (United States)
ATC codeC07AA06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6131422405
    5 mL in 1 BOTTLE (61314-224-05)
  • ndc11
    6131422425
    2.5 mL in 1 BOTTLE (61314-224-25)

Annotations

UNII (FDA Substance ID)
P8Y54F701R
TIMOLOL MALEATE
RxCUI 42933
Orange Book
N020963
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": "61314-224_ba538348-67cf-4031-84e5-cb84647af104",
  "productndc": "61314-224",
  "dosage_form": "SOLUTION, GEL FORMING / DROPS",
  "orange_book": {
    "appl_no": "020963",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 0.25% BASE",
        "product_no": "001",
        "approval_date": "Oct 21, 1998"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 0.5% BASE",
        "product_no": "002",
        "approval_date": "Oct 21, 1998"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TIMOLOL MALEATE",
  "proprietary_name": "Timolol GFS",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA020963",
  "marketing_category": "NDA",
  "nonproprietary_name": "timolol maleate",
  "start_marketing_date": "19981224",
  "active_numerator_strength": "2.5"
}

Related drugs

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