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United States · US · US:57896-489_ee3ad47b-8219-3bc4-e053-2a95a90af736

POLYETHYLENE GLYCOL 3350

Orange BookUNIISPL

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

Identification

ManufacturerGeri-Care Pharmaceutical Corp
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5789648914
    238 g in 1 BOTTLE (57896-489-14)
  • ndc11
    5789648930
    510 g in 1 BOTTLE (57896-489-30)

Annotations

UNII (FDA Substance ID)
G2M7P15E5P
POLYETHYLENE GLYCOL 3350
RxCUI 221147
Orange Book
A090812
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": "57896-489_ee3ad47b-8219-3bc4-e053-2a95a90af736",
  "productndc": "57896-489",
  "dosage_form": "POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "090812",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "17GM/SCOOPFUL",
        "product_no": "001",
        "approval_date": "Oct 7, 2009"
      }
    ],
    "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": "ANDA090812",
  "marketing_category": "ANDA",
  "nonproprietary_name": "polyethylene glycol 3350",
  "start_marketing_date": "20140501",
  "active_numerator_strength": "17"
}

Access this data programmatically

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