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United States · US · US:60758-802_27ed7b7d-7640-4566-90f3-42a17a9d1a98

TIMOLOL MALEATE

Orange BookUNIISPLATC C07AA06

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

Identification

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

Packs · 2

  • ndc11
    6075880205
    1 BOTTLE, DROPPER in 1 CARTON (60758-802-05) / 5 mL in 1 BOTTLE, DROPPER
  • ndc11
    6075880210
    1 BOTTLE, DROPPER in 1 CARTON (60758-802-10) / 10 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
P8Y54F701R
TIMOLOL MALEATE
RxCUI 42933
Orange Book
A074746
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": "60758-802_27ed7b7d-7640-4566-90f3-42a17a9d1a98",
  "productndc": "60758-802",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "074746",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT1",
        "strength": "EQ 0.25% BASE",
        "product_no": "001",
        "approval_date": "Mar 25, 1997"
      }
    ],
    "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": "ANDA074746",
  "marketing_category": "ANDA",
  "nonproprietary_name": "timolol maleate",
  "start_marketing_date": "19970520",
  "active_numerator_strength": "2.5"
}

Related drugs

Other records sharing ATC code C07AA06.

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