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United States · US · US:70756-655_c1bf2590-7a5a-4213-909c-d843fdb72e08

timolol maleate

Orange BookUNIISPLATC C07AA06

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

Identification

ManufacturerLifestar Pharma LLC
CountryUS (United States)
ATC codeC07AA06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7075665530
    1 BOTTLE, DROPPER in 1 CARTON (70756-655-30) / 10 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
P8Y54F701R
TIMOLOL MALEATE
RxCUI 42933
Orange Book
A078771
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": "70756-655_c1bf2590-7a5a-4213-909c-d843fdb72e08",
  "productndc": "70756-655",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "078771",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT1",
        "strength": "EQ 0.25% BASE",
        "product_no": "001",
        "approval_date": "Sep 28, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AT1",
        "strength": "EQ 0.5% BASE",
        "product_no": "002",
        "approval_date": "Sep 28, 2009"
      }
    ],
    "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": "ANDA078771",
  "marketing_category": "ANDA",
  "nonproprietary_name": "timolol maleate",
  "start_marketing_date": "20230626",
  "active_numerator_strength": "2.5"
}

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