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United States · US · US:0591-3636_d9bd46c2-65b5-495b-acae-fcea5f775787

Trospium Chloride

Orange BookUNIISPLATC G04BD09

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

Identification

ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeG04BD09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0591363630
    30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-3636-30)

Annotations

UNII (FDA Substance ID)
1E6682427E
TROSPIUM CHLORIDE
RxCUI 38891
Orange Book
A091289
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": "0591-3636_d9bd46c2-65b5-495b-acae-fcea5f775787",
  "productndc": "0591-3636",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "091289",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "001",
        "approval_date": "Oct 12, 2012"
      }
    ],
    "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": "ANDA091289",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Trospium Chloride",
  "start_marketing_date": "20121012",
  "active_numerator_strength": "60"
}

Related drugs

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