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United States · US · US:82584-002_3891d7f3-d858-9f71-e063-6394a90af95b

BETIMOL

Orange BookUNIISPLATC C07AA06

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

Identification

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

Packs · 1

  • ndc11
    8258400205
    1 BOTTLE, DROPPER in 1 CARTON (82584-002-05) / 5 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
817W3C6175
TIMOLOL
RxCUI 221172
Orange Book
N020439
AT
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "817W3C6175",
    "rxcui": "221172",
    "inchikey": "TWBNMYSKRDRHAT-RCWTXCDDSA-N",
    "display_name": "TIMOLOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "3ae775f4-340c-4bf4-aa49-8a31daba0f8b": {
      "match": "brand_token",
      "title": "BETIMOL (TIMOLOL) SOLUTION/ DROPS [THEA PHARMA INC.]",
      "spl_version": "6",
      "published_date": "2025-06-30"
    }
  },
  "productid": "82584-002_3891d7f3-d858-9f71-e063-6394a90af95b",
  "productndc": "82584-002",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "020439",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "0.25%",
        "product_no": "001",
        "approval_date": "Mar 31, 1995"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AT",
        "strength": "0.5%",
        "product_no": "002",
        "approval_date": "Mar 31, 1995"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TIMOLOL",
  "proprietary_name": "BETIMOL",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA020439",
  "marketing_category": "NDA",
  "nonproprietary_name": "timolol",
  "start_marketing_date": "20221115",
  "active_numerator_strength": "5.12"
}

Related drugs

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