Colesevelam hydrochloride

Orange BookUNIISPLATC C10AC04

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

Identification

ManufacturerAmneal Pharmaceuticals of New York LLC

CountryUS (United States)

ATC codeC10AC04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0115186418
30 PACKET in 1 CARTON (0115-1864-18) / 1 FOR SUSPENSION in 1 PACKET (0115-1864-30)

Annotations

UNII (FDA Substance ID)

P4SG24WI5Q

COLESEVELAM HYDROCHLORIDE

RxCUI 141625

Orange Book

A212886

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": "0115-1864_83f79a9e-7658-4d89-a3aa-8c5ee39ac846",
  "productndc": "0115-1864",
  "dosage_form": "FOR SUSPENSION",
  "orange_book": {
    "appl_no": "212886",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "3.75GM/PACKET",
        "product_no": "001",
        "approval_date": "Jan 18, 2023"
      }
    ],
    "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": "ANDA212886",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Colesevelam hydrochloride",
  "start_marketing_date": "20230120",
  "active_numerator_strength": "3.75"
}

Related drugs

Other records sharing ATC code C10AC04.

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