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United States · US · US:10572-302_d21af010-592c-bd05-e053-2995a90a3d39

PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride

Orange BookUNIISPLATC C03CB

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

Identification

ManufacturerAffordable Pharmaceuticals, LLC
CountryUS (United States)
ATC codeC03CB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    1057230201
    4 L in 1 BOTTLE (10572-302-01)

Annotations

UNII (FDA Substance ID)
G2M7P15E5P
POLYETHYLENE GLYCOL 3350
RxCUI 221147
Orange Book
N019797
AAAA
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": {
    "cd9c0751-10fa-4f5f-bf29-742823541d22": {
      "match": "brand_token",
      "title": "PEG-3350, ELECTROLYTES, AND ASCORBATE (POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE, AND ASCORBIC ACID) KIT [OCEANSIDE PHARMACEUTICALS]",
      "spl_version": "5",
      "published_date": "2025-11-21"
    }
  },
  "productid": "10572-302_d21af010-592c-bd05-e053-2995a90a3d39",
  "productndc": "10572-302",
  "dosage_form": "POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "019797",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AA",
        "strength": "420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT",
        "product_no": "001",
        "approval_date": "Apr 22, 1991"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AA",
        "strength": "420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT",
        "product_no": "002",
        "approval_date": "Nov 18, 1994"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE",
  "proprietary_name": "PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride",
  "active_ingred_unit": "g/4L; g/4L; g/4L; g/4L",
  "application_number": "NDA019797",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride",
  "start_marketing_date": "20130208",
  "active_numerator_strength": "420; 1.48; 5.72; 11.2"
}

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