COLESEVELAM

Orange BookUNIISPLATC C10AC04

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

Identification

ManufacturerZydus Lifesciences Limited

CountryUS (United States)

ATC codeC10AC04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
7077113680
1000 TABLET in 1 BOTTLE (70771-1368-0)
ndc11
7077113684
10 BLISTER PACK in 1 CARTON (70771-1368-4) / 10 TABLET in 1 BLISTER PACK (70771-1368-2)
ndc11
7077113688
180 TABLET in 1 BOTTLE (70771-1368-8)

Annotations

UNII (FDA Substance ID)

P4SG24WI5Q

COLESEVELAM HYDROCHLORIDE

RxCUI 141625

Orange Book

A207765

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": "70771-1368_8bd17f3d-9ca2-4ce2-93a1-b4e9d8571079",
  "productndc": "70771-1368",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "207765",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "625MG",
        "product_no": "001",
        "approval_date": "Oct 7, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "COLESEVELAM HYDROCHLORIDE",
  "proprietary_name": "COLESEVELAM",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA207765",
  "marketing_category": "ANDA",
  "nonproprietary_name": "COLESEVELAM",
  "start_marketing_date": "20191011",
  "active_numerator_strength": "625"
}

Related drugs

Other records sharing ATC code C10AC04.

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