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United States · US · US:0115-5211_4ec79132-daa8-4439-bbd2-6f8c8c020e4f

COLESTIPOL HYDROCHLORIDE

Orange BookUNIISPLATC C10AC02

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

Identification

ManufacturerAmneal Pharmaceuticals of New York LLC
CountryUS (United States)
ATC codeC10AC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0115521102
    500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-5211-02)
  • ndc11
    0115521116
    120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-5211-16)

Annotations

UNII (FDA Substance ID)
X7D10K905G
COLESTIPOL HYDROCHLORIDE
RxCUI 104485
Orange Book
A077510
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": "0115-5211_4ec79132-daa8-4439-bbd2-6f8c8c020e4f",
  "productndc": "0115-5211",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "077510",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "1GM",
        "product_no": "001",
        "approval_date": "Oct 24, 2006"
      }
    ],
    "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": "ANDA077510",
  "marketing_category": "ANDA",
  "nonproprietary_name": "COLESTIPOL HYDROCHLORIDE",
  "start_marketing_date": "20210817",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code C10AC02.

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