Colesevelam Hydrochloride

Orange BookUNIISPLATC C10AC04

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

Identification

ManufacturerGlenmark Pharmaceuticals Inc.,USA

CountryUS (United States)

ATC codeC10AC04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6846262030
30 PACKET in 1 BOX (68462-620-30) / 1 POWDER, FOR SUSPENSION in 1 PACKET

Annotations

UNII (FDA Substance ID)

P4SG24WI5Q

COLESEVELAM HYDROCHLORIDE

RxCUI 141625

Orange Book

A202190

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": "68462-620_82044bf3-865e-4816-a6a2-f648d980fff2",
  "productndc": "68462-620",
  "dosage_form": "POWDER, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "202190",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1.875GM/PACKET",
        "product_no": "001",
        "approval_date": "Jul 16, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "3.75GM/PACKET",
        "product_no": "002",
        "approval_date": "Jul 16, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "COLESEVELAM HYDROCHLORIDE",
  "proprietary_name": "Colesevelam Hydrochloride",
  "active_ingred_unit": "g/1",
  "application_number": "ANDA202190",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Colesevelam Hydrochloride",
  "start_marketing_date": "20180716",
  "active_numerator_strength": "3.75"
}

Related drugs

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