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United States · US · US:24208-004_25b64789-6ef9-4c49-e063-6294a90a0ec4

Istalol

Orange BookUNIISPLATC C07AA06

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

Identification

ManufacturerBausch & Lomb Incorporated
CountryUS (United States)
ATC codeC07AA06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    2420800401
    1 BOTTLE, DROPPER in 1 CARTON (24208-004-01) / 2.5 mL in 1 BOTTLE, DROPPER
  • ndc11
    2420800402
    1 BOTTLE, DROPPER in 1 CARTON (24208-004-02) / 2.5 mL in 1 BOTTLE, DROPPER
  • ndc11
    2420800403
    1 BOTTLE, DROPPER in 1 CARTON (24208-004-03) / 5 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
P8Y54F701R
TIMOLOL MALEATE
RxCUI 42933
Orange Book
N021516
AT2
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": {
    "258bbc8d-00ee-45b0-ac35-6f16c4e8d45f": {
      "match": "brand_token",
      "title": "ISTALOL (TIMOLOL MALEATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]",
      "spl_version": "22",
      "published_date": "2024-11-01"
    }
  },
  "productid": "24208-004_25b64789-6ef9-4c49-e063-6294a90a0ec4",
  "productndc": "24208-004",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "021516",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AT2",
        "strength": "EQ 0.5% BASE",
        "product_no": "001",
        "approval_date": "Jun 4, 2004"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TIMOLOL MALEATE",
  "proprietary_name": "Istalol",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA021516",
  "marketing_category": "NDA",
  "nonproprietary_name": "Timolol Maleate",
  "start_marketing_date": "20040802",
  "active_numerator_strength": "5"
}

Related drugs

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