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United States · US · US:63629-8767_7802c4a7-198d-44ec-9bed-f480362c5d07

Colesevelam HCL

Orange BookUNIISPLATC C10AC04

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeC10AC04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6362987671
    180 TABLET, FILM COATED in 1 BOTTLE (63629-8767-1)

Annotations

UNII (FDA Substance ID)
P4SG24WI5Q
COLESEVELAM HYDROCHLORIDE
RxCUI 141625
Orange Book
A209038
AB
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": "63629-8767_7802c4a7-198d-44ec-9bed-f480362c5d07",
  "productndc": "63629-8767",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "209038",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "625MG",
        "product_no": "001",
        "approval_date": "Oct 5, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "COLESEVELAM HYDROCHLORIDE",
  "proprietary_name": "Colesevelam HCL",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209038",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Colesevelam HCL",
  "start_marketing_date": "20181006",
  "active_numerator_strength": "625"
}

Related drugs

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