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United States · US · US:68462-461_44d944da-d624-4016-a3eb-ce810b62fb17

Trospium Chloride

Orange BookUNIISPLATC G04BD09

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

Identification

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

Packs · 4

  • ndc11
    6846246105
    500 TABLET, FILM COATED in 1 BOTTLE (68462-461-05)
  • ndc11
    6846246110
    1000 TABLET, FILM COATED in 1 BOTTLE (68462-461-10)
  • ndc11
    6846246130
    30 TABLET, FILM COATED in 1 BOTTLE (68462-461-30)
  • ndc11
    6846246160
    60 TABLET, FILM COATED in 1 BOTTLE (68462-461-60)

Annotations

UNII (FDA Substance ID)
1E6682427E
TROSPIUM CHLORIDE
RxCUI 38891
Orange Book
A091575
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": "68462-461_44d944da-d624-4016-a3eb-ce810b62fb17",
  "productndc": "68462-461",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "091575",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Aug 13, 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": "ANDA091575",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Trospium Chloride",
  "start_marketing_date": "20100813",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code G04BD09.

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