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United States · US · US:24208-590_f7ca9591-4d7b-4c5e-b54e-e08fd8cf6755

Tropicamide

Orange BookUNIISPLATC S01FA06

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

Identification

ManufacturerBausch & Lomb Incorporated
CountryUS (United States)
ATC codeS01FA06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    2420859064
    1 BOTTLE, DROPPER in 1 CARTON (24208-590-64) / 15 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
N0A3Z5XTC6
TROPICAMIDE
RxCUI 10869
Orange Book
A040067
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": "24208-590_f7ca9591-4d7b-4c5e-b54e-e08fd8cf6755",
  "productndc": "24208-590",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "040067",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "0.5%",
        "product_no": "001",
        "approval_date": "Jul 27, 1994"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TROPICAMIDE",
  "proprietary_name": "Tropicamide",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA040067",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tropicamide",
  "start_marketing_date": "19940727",
  "active_numerator_strength": "5"
}

Related drugs

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