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United States · US · US:61314-354_2fbad93e-d3da-4a31-9a78-66a923ce78ba

Tropicamide

Orange BookUNIISPLATC S01FA06

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

Identification

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

Packs · 1

  • ndc11
    6131435401
    1 BOTTLE, PLASTIC in 1 CARTON (61314-354-01) / 15 mL in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
N0A3Z5XTC6
TROPICAMIDE
RxCUI 10869
Orange Book
A084305
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": "61314-354_2fbad93e-d3da-4a31-9a78-66a923ce78ba",
  "productndc": "61314-354",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "084305",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AT",
        "strength": "0.5%",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TROPICAMIDE",
  "proprietary_name": "Tropicamide",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA084305",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tropicamide",
  "start_marketing_date": "20000609",
  "active_numerator_strength": "5"
}

Related drugs

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