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United States · US · US:52536-302_4e442a72-b13b-4869-8a1d-59356095b091

PEG

Orange BookUNIISPLATC C03CB

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

Identification

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

Packs · 1

  • ndc11
    5253630201
    4 L in 1 BOTTLE (52536-302-01)

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": {
    "b251752d-7750-482a-9364-0acf4ad47cc8": {
      "match": "brand_token",
      "title": "PEG 3350 AND ELECTROLYTES (POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE) POWDER, FOR SOLUTION [WILSHIRE PHARMACEUTICALS, INC.]",
      "spl_version": "1",
      "published_date": "2026-04-23"
    }
  },
  "productid": "52536-302_4e442a72-b13b-4869-8a1d-59356095b091",
  "productndc": "52536-302",
  "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",
  "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": "20260415",
  "active_numerator_strength": "420; 1.48; 5.72; 11.2"
}

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