CHOLESTYRAMINE

Orange BookUNIISPLATC C10AC01

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

Identification

ManufacturerZydus Pharmaceuticals (USA) Inc.

CountryUS (United States)

ATC codeC10AC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6838252942
231 g in 1 CONTAINER (68382-529-42)
ndc11
6838252960
60 POUCH in 1 CARTON (68382-529-60) / 5.5 g in 1 POUCH

Annotations

UNII (FDA Substance ID)

4B33BGI082

CHOLESTYRAMINE

RxCUI 2447

Orange Book

A202902

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": "68382-529_11d83a73-e97b-466d-9af9-2882e7a094b2",
  "productndc": "68382-529",
  "dosage_form": "POWDER, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "202902",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 4GM RESIN/SCOOPFUL",
        "product_no": "001",
        "approval_date": "Apr 25, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 4GM RESIN/PACKET",
        "product_no": "002",
        "approval_date": "Apr 25, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CHOLESTYRAMINE",
  "proprietary_name": "CHOLESTYRAMINE",
  "active_ingred_unit": "g/5.5g",
  "application_number": "ANDA202902",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CHOLESTYRAMINE",
  "start_marketing_date": "20170608",
  "active_numerator_strength": "4"
}

Related drugs

Other records sharing ATC code C10AC01.

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