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United States · US · US:85766-040_4a2ba794-da99-91aa-e063-6394a90a8370

Tropicamide

Orange BookUNIISPLATC S01FA06

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

Identification

ManufacturerSportpharm LLC
CountryUS (United States)
ATC codeS01FA06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8576604015
    1 BOTTLE in 1 CARTON (85766-040-15) / 15 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
N0A3Z5XTC6
TROPICAMIDE
RxCUI 10869
Orange Book
A207524
AT
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "N0A3Z5XTC6",
    "rxcui": "10869",
    "inchikey": "BGDKAVGWHJFAGW-UHFFFAOYSA-N",
    "display_name": "TROPICAMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "378b5fe2-4b5d-4c87-a7d6-fd0caa6402af": {
      "match": "brand_token",
      "title": "TROPICAMIDE SOLUTION/ DROPS [SOMERSET THERAPEUTICS, LLC]",
      "spl_version": "9",
      "published_date": "2026-05-13"
    }
  },
  "productid": "85766-040_4a2ba794-da99-91aa-e063-6394a90a8370",
  "productndc": "85766-040",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "207524",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "1%",
        "product_no": "001",
        "approval_date": "Dec 12, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TROPICAMIDE",
  "proprietary_name": "Tropicamide",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA207524",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tropicamide",
  "start_marketing_date": "20191212",
  "active_numerator_strength": "10"
}

Related drugs

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