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United States · US · US:72789-348_40bb63a7-468a-a247-e063-6394a90acced

TROSPIUM CHLORIDE

Orange BookUNIISPLATC G04BD09

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

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeG04BD09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7278934860
    60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-348-60)

Annotations

UNII (FDA Substance ID)
1E6682427E
TROSPIUM CHLORIDE
RxCUI 38891
Orange Book
A091573
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": "72789-348_40bb63a7-468a-a247-e063-6394a90acced",
  "productndc": "72789-348",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "091573",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Nov 17, 2010"
      }
    ],
    "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": "ANDA091573",
  "marketing_category": "ANDA",
  "nonproprietary_name": "TROSPIUM CHLORIDE",
  "start_marketing_date": "20101117",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code G04BD09.

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