COLESTIPOL HYDROCHLORIDE

Orange BookUNIISPLATC C10AC02

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

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 · 1

ndc11
0115521302
100 SUSPENSION in 1 BOTTLE (0115-5213-02)

Annotations

UNII (FDA Substance ID)

X7D10K905G

COLESTIPOL HYDROCHLORIDE

RxCUI 104485

Orange Book

A077277

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": "0115-5213_78f0e0f5-e61e-4c11-8e35-b65bcdfcfc06",
  "productndc": "0115-5213",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "077277",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5GM/SCOOPFUL",
        "product_no": "001",
        "approval_date": "May 2, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5GM/PACKET",
        "product_no": "002",
        "approval_date": "May 2, 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": "ANDA077277",
  "marketing_category": "ANDA",
  "nonproprietary_name": "COLESTIPOL HYDROCHLORIDE",
  "start_marketing_date": "20060502",
  "active_numerator_strength": "5"
}

Related drugs

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