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United States · US · US:70518-4593_502530ff-ea3c-2d59-e063-6394a90a3345

Trospium Chloride

Orange BookUNIISPLATC G04BD09

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

Identification

ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeG04BD09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    7051845930
    30 POUCH in 1 BOX (70518-4593-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4593-1)
  • ndc11
    7051845932
    60 POUCH in 1 BOX (70518-4593-2) / 1 TABLET, FILM COATED in 1 POUCH (70518-4593-1)
  • ndc11
    7051845933
    100 POUCH in 1 BOX (70518-4593-3) / 1 TABLET, FILM COATED in 1 POUCH (70518-4593-1)
  • ndc11
    7051845934
    50 POUCH in 1 BOX (70518-4593-4) / 1 TABLET, FILM COATED in 1 POUCH (70518-4593-1)

Annotations

UNII (FDA Substance ID)
1E6682427E
TROSPIUM CHLORIDE
RxCUI 38891
Orange Book
A204945
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": "70518-4593_502530ff-ea3c-2d59-e063-6394a90a3345",
  "productndc": "70518-4593",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "204945",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Aug 30, 2016"
      }
    ],
    "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": "ANDA204945",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Trospium Chloride",
  "start_marketing_date": "20260323",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code G04BD09.

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