Colesevelam Hydrochloride

Orange BookUNIISPLATC C10AC04

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

Identification

ManufacturerDr.Reddys Laboratories Inc

CountryUS (United States)

ATC codeC10AC04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4359823018
180 TABLET in 1 BOTTLE (43598-230-18)

Annotations

UNII (FDA Substance ID)

P4SG24WI5Q

COLESEVELAM HYDROCHLORIDE

RxCUI 141625

Orange Book

A210889

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": "43598-230_1afa82f5-9ea2-5d75-688e-a44a867bd377",
  "productndc": "43598-230",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "210889",
    "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 Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210889",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Colesevelam Hydrochloride",
  "start_marketing_date": "20181005",
  "active_numerator_strength": "625"
}

Related drugs

Other records sharing ATC code C10AC04.

Access this data programmatically

Query Colesevelam Hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs