Polyethylene Glycol 3350

Orange BookUNIISPL

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5167221043
765 g in 1 CAN (51672-2104-3)

Annotations

UNII (FDA Substance ID)

G2M7P15E5P

POLYETHYLENE GLYCOL 3350

RxCUI 221147

Orange Book

A203928

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": "51672-2104_43e02980-58b9-7991-e063-6294a90a7a29",
  "productndc": "51672-2104",
  "dosage_form": "POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "203928",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "17GM/SCOOPFUL",
        "product_no": "001",
        "approval_date": "Aug 24, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "17GM/PACKET",
        "product_no": "002",
        "approval_date": "Aug 24, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "POLYETHYLENE GLYCOL 3350",
  "proprietary_name": "Polyethylene Glycol 3350",
  "active_ingred_unit": "g/17g",
  "application_number": "ANDA203928",
  "marketing_category": "ANDA",
  "nonproprietary_name": "InstaLax Polyethylene Glycol 3350",
  "start_marketing_date": "20251009",
  "active_numerator_strength": "17"
}

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