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United States Β· US Β· US:65649-201_1e0ca4a8-3483-40c3-b75f-6ae9cea97652

MoviPrep

Orange BookSPL

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

Identification

ManufacturerSalix Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeβ€”
Dispensingβ€”
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs Β· 2

  • ndc11
    6564920175
    1 KIT in 1 CONTAINER (65649-201-75) * 1 L in 1 POUCH * 1 L in 1 POUCH
  • ndc11
    6564920176
    1 KIT in 1 CONTAINER (65649-201-76) * 1 L in 1 POUCH * 1 L in 1 POUCH

Annotations

Orange Book
N021881
AA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "8ff46193-2a3b-4de0-9572-775dda8cd8b2": {
      "match": "brand_token",
      "title": "MOVIPREP (POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATE) KIT [SALIX PHARMACEUTICALS, INC.]",
      "spl_version": "46",
      "published_date": "2025-12-24"
    }
  },
  "productid": "65649-201_1e0ca4a8-3483-40c3-b75f-6ae9cea97652",
  "productndc": "65649-201",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "021881",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AA",
        "strength": "4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM",
        "product_no": "001",
        "approval_date": "Aug 2, 2006"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "MoviPrep",
  "active_ingred_unit": null,
  "application_number": "NDA021881",
  "marketing_category": "NDA",
  "nonproprietary_name": "POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATE",
  "start_marketing_date": "20061001",
  "active_numerator_strength": null
}

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MoviPrep (US) β€” Drug Database