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United States · US · US:33342-554_4d3cbe46-addd-4a3e-850d-ce502fd5cd26

Trospium Chloride

Orange BookUNIISPLATC G04BD09

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

Identification

ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeG04BD09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    3334255409
    60 TABLET in 1 BOTTLE (33342-554-09)
  • ndc11
    3334255439
    6 BLISTER PACK in 1 CARTON (33342-554-39) / 15 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
1E6682427E
TROSPIUM CHLORIDE
RxCUI 38891
Orange Book
A206472
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "1E6682427E",
    "rxcui": "38891",
    "inchikey": "RVCSYOQWLPPAOA-QKYUOBHYSA-M",
    "display_name": "TROSPIUM CHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "c1c8bd8b-7ff8-5940-e053-2995a90ae656": {
      "match": "brand_token",
      "title": "TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [SLATE RUN PHARMACEUTICALS, LLC]",
      "spl_version": "13",
      "published_date": "2026-05-21"
    }
  },
  "productid": "33342-554_4d3cbe46-addd-4a3e-850d-ce502fd5cd26",
  "productndc": "33342-554",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "206472",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Jun 18, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TROSPIUM CHLORIDE",
  "proprietary_name": "Trospium Chloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206472",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Trospium Chloride",
  "start_marketing_date": "20240618",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code G04BD09.

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