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United States · US · US:70069-698_c1213979-d6ff-44c2-ad97-1de99ddcf8d2

Timolol Hemihydrate

Orange BookUNIISPLATC C07AA06

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

Identification

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

Packs · 1

  • ndc11
    7006969801
    1 BOTTLE in 1 CARTON (70069-698-01) / 15 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
5JKY92S7BR
TIMOLOL ANHYDROUS
RxCUI 1546004
Orange Book
A216654
AT
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "5JKY92S7BR",
    "rxcui": "1546004",
    "inchikey": "BLJRIMJGRPQVNF-JTQLQIEISA-N",
    "display_name": "TIMOLOL ANHYDROUS",
    "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": "70069-698_c1213979-d6ff-44c2-ad97-1de99ddcf8d2",
  "productndc": "70069-698",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "216654",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "0.5%",
        "product_no": "001",
        "approval_date": "Oct 10, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TIMOLOL ANHYDROUS",
  "proprietary_name": "Timolol Hemihydrate",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA216654",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Timolol Hemihydrate",
  "start_marketing_date": "20241031",
  "active_numerator_strength": "5"
}

Related drugs

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