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United States · US · US:72162-1106_849b6114-1cf2-4e15-a3aa-01abd680a6af

Trospium Chloride

Orange BookUNIISPLATC G04BD09

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeG04BD09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7216211061
    100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-1106-1)
  • ndc11
    7216211063
    30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-1106-3)

Annotations

UNII (FDA Substance ID)
1E6682427E
TROSPIUM CHLORIDE
RxCUI 38891
Orange Book
A201291
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": "72162-1106_849b6114-1cf2-4e15-a3aa-01abd680a6af",
  "productndc": "72162-1106",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "201291",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "001",
        "approval_date": "May 24, 2013"
      }
    ],
    "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": "ANDA201291",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Trospium Chloride",
  "start_marketing_date": "20130607",
  "active_numerator_strength": "60"
}

Related drugs

Other records sharing ATC code G04BD09.

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