Polyethylene Glycol (3350)

Orange BookUNIISPL

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

Identification

ManufacturerMylan Institutional Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5107930630
30 POUCH in 1 CARTON (51079-306-30) / 17 g in 1 POUCH (51079-306-01)

Annotations

UNII (FDA Substance ID)

FVS1AZD90Y

POLYETHYLENE GLYCOL 3500

RxCUI 1312707

Orange Book

A078915

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "FVS1AZD90Y",
    "rxcui": "1312707",
    "inchikey": null,
    "display_name": "POLYETHYLENE GLYCOL 3500",
    "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": "51079-306_e67ef7f0-6cb2-4f99-b29c-e4f122e2e250",
  "productndc": "51079-306",
  "dosage_form": "POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "078915",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "17GM/PACKET",
        "product_no": "001",
        "approval_date": "Oct 6, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "17GM/SCOOPFUL",
        "product_no": "002",
        "approval_date": "Oct 6, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "POLYETHYLENE GLYCOL 3500",
  "proprietary_name": "Polyethylene Glycol (3350)",
  "active_ingred_unit": "g/17g",
  "application_number": "ANDA078915",
  "marketing_category": "ANDA",
  "nonproprietary_name": "polyethylene glycol (3350)",
  "start_marketing_date": "20091012",
  "active_numerator_strength": "17"
}

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