Colesevelam hydrochloride

Orange BookUNIISPLATC C10AC04

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

Identification

ManufacturerCranbury Pharmaceuticals, LLC

CountryUS (United States)

ATC codeC10AC04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
2780819001
180 TABLET in 1 BOTTLE (27808-190-01)

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": "27808-190_47df1b20-2cfd-483e-94cc-232339869d17",
  "productndc": "27808-190",
  "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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