Colesevelam Hydrochloride

Orange BookUNIISPLATC C10AC04

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerMacleods Pharmaceuticals Limited

CountryUS (United States)

ATC codeC10AC04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
3334219757
180 TABLET, FILM COATED in 1 BOTTLE (33342-197-57)

Annotations

UNII (FDA Substance ID)

P4SG24WI5Q

COLESEVELAM HYDROCHLORIDE

RxCUI 141625

Orange Book

A204893

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "P4SG24WI5Q",
    "rxcui": "141625",
    "inchikey": null,
    "display_name": "COLESEVELAM HYDROCHLORIDE",
    "substance_type": "polymer",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "dbed6967-b261-44a1-bee4-638810e2efe9": {
      "match": "brand_token",
      "title": "COLESEVELAM HYDROCHLORIDE POWDER, FOR SUSPENSION [BRYANT RANCH PREPACK]",
      "spl_version": "103",
      "published_date": "2026-05-28"
    }
  },
  "productid": "33342-197_c2075dd1-e33c-4438-95f8-1897f0e1f61a",
  "productndc": "33342-197",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "204893",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "625MG",
        "product_no": "001",
        "approval_date": "Apr 18, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "COLESEVELAM HYDROCHLORIDE",
  "proprietary_name": "Colesevelam Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204893",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Colesevelam Hydrochloride",
  "start_marketing_date": "20250418",
  "active_numerator_strength": "625"
}

Related drugs

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