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United States · US · US:69168-473_3f5e8be5-96ac-462d-94b1-d8caaac1bf3a

Polyethylene Gycol 3350

Orange BookUNIISPL

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

Identification

ManufacturerAllegiant Health
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    6916847355
    510 g in 1 BOTTLE (69168-473-55)
  • ndc11
    6916847356
    238 g in 1 BOTTLE (69168-473-56)
  • ndc11
    6916847361
    238 g in 1 BOTTLE (69168-473-61)
  • ndc11
    6916847362
    510 g in 1 BOTTLE (69168-473-62)

Annotations

UNII (FDA Substance ID)
G2M7P15E5P
POLYETHYLENE GLYCOL 3350
RxCUI 221147
Orange Book
A214990
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": "69168-473_3f5e8be5-96ac-462d-94b1-d8caaac1bf3a",
  "productndc": "69168-473",
  "dosage_form": "POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "214990",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "17GM/SCOOPFUL",
        "product_no": "001",
        "approval_date": "Apr 14, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "17GM/PACKET",
        "product_no": "002",
        "approval_date": "Apr 14, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "POLYETHYLENE GLYCOL 3350",
  "proprietary_name": "Polyethylene Gycol 3350",
  "active_ingred_unit": "g/g",
  "application_number": "ANDA214990",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Polyethylene Gycol 3350",
  "start_marketing_date": "20250317",
  "active_numerator_strength": "17"
}

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