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United States · US · US:79739-7116_fc3454ec-7729-4327-90f7-9e12dddb19d6

Polyethylene Glycol 3350, NF Powder for Solution, Laxative

Orange BookUNIISPL

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

Identification

ManufacturerLGM PHARMA SOLUTIONS, LLC
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7973971161
    7 d in 1 BOTTLE (79739-7116-1)
  • ndc11
    7973971162
    14 d in 1 BOTTLE (79739-7116-2)
  • ndc11
    7973971163
    30 d in 1 BOTTLE (79739-7116-3)

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": "79739-7116_fc3454ec-7729-4327-90f7-9e12dddb19d6",
  "productndc": "79739-7116",
  "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, NF Powder for Solution, Laxative",
  "active_ingred_unit": "g/d",
  "application_number": "ANDA090812",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Polyethylene Glycol 3350, NF Powder for Solution, Laxative",
  "start_marketing_date": "20091007",
  "active_numerator_strength": "17"
}

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