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United States · US · US:65649-400_c23688c3-a0ff-40bd-aa0c-9ebee4f69119

Plenvu

Orange BookSPL

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

Identification

ManufacturerSalix Pharmaceuticals, Inc
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6564940001
    1 KIT in 1 CARTON (65649-400-01) * 46.26 POWDER, FOR SOLUTION in 1 POUCH * 55.65 POWDER, FOR SOLUTION in 1 POUCH * 115.96 POWDER, FOR SOLUTION in 1 POUCH
  • ndc11
    6564940002
    1 KIT in 1 CARTON (65649-400-02) * 46.26 POWDER, FOR SOLUTION in 1 POUCH * 55.65 POWDER, FOR SOLUTION in 1 POUCH * 115.96 POWDER, FOR SOLUTION in 1 POUCH

Annotations

Orange Book
N209381
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "79f930fa-5674-4f30-8ae8-9448d6243797": {
      "match": "brand_token",
      "title": "PLENVU (POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATE) KIT [SALIX PHARMACEUTICALS, INC]",
      "spl_version": "12",
      "published_date": "2023-11-15"
    }
  },
  "productid": "65649-400_c23688c3-a0ff-40bd-aa0c-9ebee4f69119",
  "productndc": "65649-400",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "209381",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM",
        "product_no": "001",
        "approval_date": "May 4, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Plenvu",
  "active_ingred_unit": null,
  "application_number": "NDA209381",
  "marketing_category": "NDA",
  "nonproprietary_name": "POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATE",
  "start_marketing_date": "20180504",
  "active_numerator_strength": null
}

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