Colesevelam hydrochloride

Orange BookUNIISPLATC C10AC04

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeC10AC04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009076050
90 TABLET in 1 BOTTLE (50090-7605-0)

Annotations

UNII (FDA Substance ID)

P4SG24WI5Q

COLESEVELAM HYDROCHLORIDE

RxCUI 141625

Orange Book

A209946

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": "50090-7605_5f82c8bd-3c74-446a-92b5-572f85eb6376",
  "productndc": "50090-7605",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "209946",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "625MG",
        "product_no": "001",
        "approval_date": "Jul 15, 2020"
      }
    ],
    "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": "ANDA209946",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Colesevelam hydrochloride",
  "start_marketing_date": "20201019",
  "active_numerator_strength": "625"
}

Related drugs

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