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United States · US · US:64980-514_7ef88352-6fe4-48a4-b72b-15419d3ed051

TIMOLOL MALEATE

Orange BookUNIISPLATC C07AA06

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

Identification

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

Packs · 3

  • ndc11
    6498051401
    1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE
  • ndc11
    6498051405
    1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE
  • ndc11
    6498051415
    1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
P8Y54F701R
TIMOLOL MALEATE
RxCUI 42933
Orange Book
A077259
AT1AT1
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": "64980-514_7ef88352-6fe4-48a4-b72b-15419d3ed051",
  "productndc": "64980-514",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "077259",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT1",
        "strength": "EQ 0.25% BASE",
        "product_no": "001",
        "approval_date": "Apr 30, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AT1",
        "strength": "EQ 0.5% BASE",
        "product_no": "002",
        "approval_date": "Apr 30, 2008"
      }
    ],
    "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": "ANDA077259",
  "marketing_category": "ANDA",
  "nonproprietary_name": "timolol maleate",
  "start_marketing_date": "20141215",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code C07AA06.

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