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United States · US · US:51224-011_94d7bc24-2f81-463b-b646-92fbf6641f71

Cholestyramine

Orange BookUNIISPLATC C10AC01

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

Identification

ManufacturerTAGI Pharma, Inc.
CountryUS (United States)
ATC codeC10AC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5122401110
    348.6 g in 1 CAN (51224-011-10)
  • ndc11
    5122401120
    60 POUCH in 1 CARTON (51224-011-20) / 8.3 g in 1 POUCH

Annotations

UNII (FDA Substance ID)
4B33BGI082
CHOLESTYRAMINE
RxCUI 2447
Orange Book
A209597
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "4B33BGI082",
    "rxcui": "2447",
    "inchikey": null,
    "display_name": "CHOLESTYRAMINE",
    "substance_type": "polymer",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "acc48703-c15b-4275-aa75-749f1c07dcbb": {
      "match": "brand_token",
      "title": "CHOLESTYRAMINE POWDER, FOR SUSPENSION [ZYDUS PHARMACEUTICALS (USA) INC.]",
      "spl_version": "6",
      "published_date": "2026-04-29"
    }
  },
  "productid": "51224-011_94d7bc24-2f81-463b-b646-92fbf6641f71",
  "productndc": "51224-011",
  "dosage_form": "POWDER, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "209597",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 4GM RESIN/PACKET",
        "product_no": "001",
        "approval_date": "Mar 9, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 4GM RESIN/SCOOPFUL",
        "product_no": "002",
        "approval_date": "Mar 9, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CHOLESTYRAMINE",
  "proprietary_name": "Cholestyramine",
  "active_ingred_unit": "g/8.3g",
  "application_number": "ANDA209597",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cholestyramine",
  "start_marketing_date": "20210310",
  "active_numerator_strength": "4"
}

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