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United States · US · US:24208-816_cb6890c5-7788-453b-910d-10c2bee17d04

Timoptic-XE

Orange BookUNIIATC C07AA06

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

Identification

ManufacturerBausch & Lomb Incorporated
CountryUS (United States)
ATC codeC07AA06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    2420881605
    1 BOTTLE, DISPENSING in 1 CARTON (24208-816-05) / 5 mL in 1 BOTTLE, DISPENSING

Annotations

UNII (FDA Substance ID)
P8Y54F701R
TIMOLOL MALEATE
RxCUI 42933
Orange Book
N020330
ABAB
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",
  "productid": "24208-816_cb6890c5-7788-453b-910d-10c2bee17d04",
  "productndc": "24208-816",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "020330",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 0.25% BASE",
        "product_no": "001",
        "approval_date": "Nov 4, 1993"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 0.5% BASE",
        "product_no": "002",
        "approval_date": "Nov 4, 1993"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TIMOLOL MALEATE",
  "proprietary_name": "Timoptic-XE",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA020330",
  "marketing_category": "NDA",
  "nonproprietary_name": "Timolol Maleate",
  "start_marketing_date": "20160531",
  "active_numerator_strength": "5"
}

Related drugs

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