Prevalite

Orange BookUNIISPLATC C10AC01

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

Identification

ManufacturerUpsher-Smith Laboratories, LLC

CountryUS (United States)

ATC codeC10AC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
0245003623
231 g in 1 CAN (0245-0036-23)
ndc11
0245003642
42 PACKET in 1 CARTON (0245-0036-42) / 5.5 g in 1 PACKET (0245-0036-89)
ndc11
0245003660
60 PACKET in 1 CARTON (0245-0036-60) / 5.5 g in 1 PACKET (0245-0036-89)

Annotations

UNII (FDA Substance ID)

4B33BGI082

CHOLESTYRAMINE

RxCUI 2447

Orange Book

A073263

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": {
    "dd434ef8-8af3-434c-a0a0-9a0b18459ba0": {
      "match": "brand_token",
      "title": "PREVALITE (CHOLESTYRAMINE) POWDER, FOR SUSPENSION [UPSHER-SMITH LABORATORIES, LLC]",
      "spl_version": "9",
      "published_date": "2025-12-04"
    }
  },
  "productid": "0245-0036_44feb603-0970-9b63-e063-6294a90a7ce5",
  "productndc": "0245-0036",
  "dosage_form": "POWDER, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "073263",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 4GM RESIN/PACKET",
        "product_no": "001",
        "approval_date": "Feb 22, 1996"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 4GM RESIN/SCOOPFUL",
        "product_no": "002",
        "approval_date": "Oct 30, 1997"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CHOLESTYRAMINE",
  "proprietary_name": "Prevalite",
  "active_ingred_unit": "g/5.5g",
  "application_number": "ANDA073263",
  "marketing_category": "ANDA",
  "nonproprietary_name": "cholestyramine",
  "start_marketing_date": "19960201",
  "active_numerator_strength": "4"
}

Related drugs

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