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United States · US · US:59762-0260_a0444824-730e-4e63-9ddf-54461b1c4900

Colestipol Hydrochloride

Orange BookUNIISPLATC C10AC02

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

Identification

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

Packs · 3

  • ndc11
    5976202601
    30 PACKET in 1 CARTON (59762-0260-1) / 5 g in 1 PACKET
  • ndc11
    5976202602
    90 PACKET in 1 CARTON (59762-0260-2) / 5 g in 1 PACKET
  • ndc11
    5976202603
    500 g in 1 BOTTLE (59762-0260-3)

Annotations

UNII (FDA Substance ID)
X7D10K905G
COLESTIPOL HYDROCHLORIDE
RxCUI 104485
Orange Book
N017563
ABAB
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": "59762-0260_a0444824-730e-4e63-9ddf-54461b1c4900",
  "productndc": "59762-0260",
  "dosage_form": "GRANULE, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "017563",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5GM/PACKET",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5GM/SCOOPFUL",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "5GM/SCOOPFUL",
        "product_no": "003",
        "approval_date": "Sep 22, 1995"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "5GM/PACKET",
        "product_no": "004",
        "approval_date": "Sep 22, 1995"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "COLESTIPOL HYDROCHLORIDE",
  "proprietary_name": "Colestipol Hydrochloride",
  "active_ingred_unit": "g/5g",
  "application_number": "NDA017563",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Colestipol Hydrochloride",
  "start_marketing_date": "19770404",
  "active_numerator_strength": "5"
}

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