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United States · US · US:42799-115_440d1d49-3eb7-42db-8536-9f0a91c46532

Colestipol Hydrochloride

Orange BookUNIISPLATC C10AC02

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

Identification

ManufacturerEdenbridge Pharmaceuticals LLC.
CountryUS (United States)
ATC codeC10AC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4279911501
    120 TABLET in 1 BOTTLE (42799-115-01)

Annotations

UNII (FDA Substance ID)
X7D10K905G
COLESTIPOL HYDROCHLORIDE
RxCUI 104485
Orange Book
A217667
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "X7D10K905G",
    "rxcui": "104485",
    "inchikey": null,
    "display_name": "COLESTIPOL HYDROCHLORIDE",
    "substance_type": "polymer",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "153e9154-1804-4d73-94b7-a31a1d37c420": {
      "match": "brand_token",
      "title": "COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]",
      "spl_version": "5",
      "published_date": "2025-11-17"
    }
  },
  "productid": "42799-115_440d1d49-3eb7-42db-8536-9f0a91c46532",
  "productndc": "42799-115",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "217667",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1GM",
        "product_no": "001",
        "approval_date": "Aug 16, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "COLESTIPOL HYDROCHLORIDE",
  "proprietary_name": "Colestipol Hydrochloride",
  "active_ingred_unit": "g/1",
  "application_number": "ANDA217667",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Colestipol Hydrochloride",
  "start_marketing_date": "20241126",
  "active_numerator_strength": "1"
}

Related drugs

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