Polyethylene Glycol 3350

Orange BookUNIISPL

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

Identification

ManufacturerANI Pharmaceuticals, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6255915710
100 PACKET in 1 CARTON (62559-157-10) / 17 g in 1 PACKET (62559-157-17)
ndc11
6255915730
30 PACKET in 1 CARTON (62559-157-30) / 17 g in 1 PACKET (62559-157-17)

Annotations

UNII (FDA Substance ID)

G2M7P15E5P

POLYETHYLENE GLYCOL 3350

RxCUI 221147

Orange Book

A202850

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": "62559-157_62f5ef8d-cbde-464f-8dd6-c087053dfd42",
  "productndc": "62559-157",
  "dosage_form": "POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "202850",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "17GM/SCOOPFUL",
        "product_no": "001",
        "approval_date": "Dec 15, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "17GM/PACKET",
        "product_no": "002",
        "approval_date": "Nov 30, 2021"
      }
    ],
    "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": "ANDA202850",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Polyethylene Glycol 3350",
  "start_marketing_date": "20200324",
  "active_numerator_strength": "17"
}

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