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United States · US · US:67877-506_6289ed62-26fb-4c9e-971a-39a5e53c5c2e

Colesevelam HCL

Orange BookUNIISPLATC C10AC04

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

Identification

ManufacturerAscend Laboratories, LLC
CountryUS (United States)
ATC codeC10AC04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    6787750605
    500 TABLET, FILM COATED in 1 BOTTLE (67877-506-05)
  • ndc11
    6787750630
    30 TABLET, FILM COATED in 1 BOTTLE (67877-506-30)
  • ndc11
    6787750651
    180 TABLET, FILM COATED in 1 BOTTLE (67877-506-51)
  • ndc11
    6787750690
    90 TABLET, FILM COATED in 1 BOTTLE (67877-506-90)

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": "67877-506_6289ed62-26fb-4c9e-971a-39a5e53c5c2e",
  "productndc": "67877-506",
  "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

Other records sharing ATC code C10AC04.

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