Polyethylene Glycol 3350 and electrolytes - Unflavored

Orange BookUNIISPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerStrides Pharma Science Limited

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6438076521
4 L in 1 JUG (64380-765-21)

Annotations

UNII (FDA Substance ID)

G2M7P15E5P

POLYETHYLENE GLYCOL 3350

RxCUI 221147

Orange Book

A204558

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": "64380-765_d0b5c5be-e56a-4c27-909e-188913075072",
  "productndc": "64380-765",
  "dosage_form": "POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "204558",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT",
        "product_no": "001",
        "approval_date": "Dec 21, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORATE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS",
  "proprietary_name": "Polyethylene Glycol 3350 and electrolytes - Unflavored",
  "active_ingred_unit": "g/4L; g/4L; g/4L; g/4L; g/4L",
  "application_number": "ANDA204558",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Polyethylene Glycol 3350 and electrolytes - Unflavored",
  "start_marketing_date": "20190110",
  "active_numerator_strength": "236; 2.97; 6.74; 5.86; 22.74"
}

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