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United States · US · US:50090-7837_bc369d21-0492-493e-9929-2cae44fd9b9b

Timolol Maleate

Orange BookUNIISPLATC C07AA06

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeC07AA06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009078370
    1 BOTTLE in 1 CARTON (50090-7837-0) / 10 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
P8Y54F701R
TIMOLOL MALEATE
RxCUI 42933
Orange Book
A218460
AT1
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": "50090-7837_bc369d21-0492-493e-9929-2cae44fd9b9b",
  "productndc": "50090-7837",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "218460",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT1",
        "strength": "EQ 0.5% BASE",
        "product_no": "001",
        "approval_date": "Aug 7, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TIMOLOL MALEATE",
  "proprietary_name": "Timolol Maleate",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA218460",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Timolol Maleate",
  "start_marketing_date": "20240916",
  "active_numerator_strength": "5"
}

Related drugs

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