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United States · US · US:33342-319_c41529f1-16d2-4ca3-91eb-f809571f5ae3

Cholestyramine

Orange BookUNIISPLATC C10AC01

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

Identification

ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeC10AC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    3334231970
    60 POUCH in 1 CARTON (33342-319-70) / 5.7 g in 1 POUCH (33342-319-01)
  • ndc11
    3334231972
    42 POUCH in 1 CARTON (33342-319-72) / 5.7 g in 1 POUCH (33342-319-01)
  • ndc11
    3334231983
    239.4 g in 1 JAR (33342-319-83)

Annotations

UNII (FDA Substance ID)
4B33BGI082
CHOLESTYRAMINE
RxCUI 2447
Orange Book
A209109
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": "33342-319_c41529f1-16d2-4ca3-91eb-f809571f5ae3",
  "productndc": "33342-319",
  "dosage_form": "POWDER, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "209109",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 4GM RESIN/SCOOPFUL",
        "product_no": "001",
        "approval_date": "Oct 31, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 4GM RESIN/PACKET",
        "product_no": "002",
        "approval_date": "Oct 31, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CHOLESTYRAMINE",
  "proprietary_name": "Cholestyramine",
  "active_ingred_unit": "g/5.7g",
  "application_number": "ANDA209109",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cholestyramine",
  "start_marketing_date": "20241121",
  "active_numerator_strength": "4"
}

Related drugs

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