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United States · US · US:72485-602_9173b81c-8ae8-4b3b-a0b8-2530a1462616

Timolol maleate

Orange BookUNIISPLATC C07AA06

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

Identification

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

Packs · 1

  • ndc11
    7248560260
    6 POUCH in 1 CARTON (72485-602-60) / 10 VIAL in 1 POUCH (72485-602-05) / .3 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
P8Y54F701R
TIMOLOL MALEATE
RxCUI 42933
Orange Book
A217195
AT3
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": "72485-602_9173b81c-8ae8-4b3b-a0b8-2530a1462616",
  "productndc": "72485-602",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "217195",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT3",
        "strength": "EQ 0.5% BASE",
        "product_no": "001",
        "approval_date": "May 8, 2023"
      }
    ],
    "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": "ANDA217195",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Timolol maleate",
  "start_marketing_date": "20230508",
  "active_numerator_strength": "6.8"
}

Related drugs

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