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United States · US · US:64380-768_5ecacfb6-b0c7-4460-820c-9a4453dd16f5

Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride - Unflavored

Orange BookUNIISPLATC C03CB

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

Identification

ManufacturerStrides Pharma Science Limited
CountryUS (United States)
ATC codeC03CB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6438076821
    4 L in 1 JUG (64380-768-21)

Annotations

UNII (FDA Substance ID)
G2M7P15E5P
POLYETHYLENE GLYCOL 3350
RxCUI 221147
Orange Book
A204559
AA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "G2M7P15E5P",
    "rxcui": "221147",
    "inchikey": null,
    "display_name": "POLYETHYLENE GLYCOL 3350",
    "substance_type": "polymer",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "ddc9d2b1-87d8-44fa-bac6-0a7261f33564": {
      "match": "brand_token",
      "title": "POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [MAJOR PHARMACEUTICALS]",
      "spl_version": "11",
      "published_date": "2026-05-25"
    }
  },
  "productid": "64380-768_5ecacfb6-b0c7-4460-820c-9a4453dd16f5",
  "productndc": "64380-768",
  "dosage_form": "POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "204559",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT",
        "product_no": "001",
        "approval_date": "Apr 13, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE",
  "proprietary_name": "Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride - Unflavored",
  "active_ingred_unit": "g/4L; g/4L; g/4L; g/4L",
  "application_number": "ANDA204559",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride - Unflavored",
  "start_marketing_date": "20150414",
  "active_numerator_strength": "420; 1.48; 5.72; 11.2"
}

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