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United States · US · US:24208-499_fb4b627c-422c-471a-bcec-fff7187d79d7

Timoptic in Ocudose

Orange BookUNIISPLATC 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 · 2

  • ndc11
    2420849900
    1 POUCH in 1 CARTON (24208-499-00) / 10 CONTAINER in 1 POUCH / .3 mL in 1 CONTAINER
  • ndc11
    2420849968
    6 POUCH in 1 CARTON (24208-499-68) / 10 CONTAINER in 1 POUCH / .3 mL in 1 CONTAINER

Annotations

UNII (FDA Substance ID)
P8Y54F701R
TIMOLOL MALEATE
RxCUI 42933
Orange Book
N019463
AT3AT3
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": {
    "16323b0e-78ae-40e5-be93-04f698dd672b": {
      "match": "brand_token",
      "title": "TIMOPTIC IN OCUDOSE (TIMOLOL MALEATE) SOLUTION [NORDIC PHARMA, INC.]",
      "spl_version": "6",
      "published_date": "2026-06-01"
    }
  },
  "productid": "24208-499_fb4b627c-422c-471a-bcec-fff7187d79d7",
  "productndc": "24208-499",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "019463",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AT3",
        "strength": "EQ 0.25% BASE",
        "product_no": "001",
        "approval_date": "Nov 5, 1986"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AT3",
        "strength": "EQ 0.5% BASE",
        "product_no": "002",
        "approval_date": "Nov 5, 1986"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TIMOLOL MALEATE",
  "proprietary_name": "Timoptic in Ocudose",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA019463",
  "marketing_category": "NDA",
  "nonproprietary_name": "Timolol Maleate",
  "start_marketing_date": "20220217",
  "active_numerator_strength": "6.8"
}

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