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United States · US · US:72603-302_2e7e711f-65c3-a4b4-e063-6294a90a85ef

Polyethylene Glycol 3350

Orange BookUNIISPL

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

Identification

ManufacturerNorthStar Rx LLC
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7260330202
    14 PACKET in 1 CARTON (72603-302-02) / 17 g in 1 PACKET (72603-302-01)
  • ndc11
    7260330203
    30 PACKET in 1 CARTON (72603-302-03) / 17 g in 1 PACKET (72603-302-01)
  • ndc11
    7260330204
    100 PACKET in 1 CARTON (72603-302-04) / 17 g in 1 PACKET (72603-302-01)

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": "72603-302_2e7e711f-65c3-a4b4-e063-6294a90a85ef",
  "productndc": "72603-302",
  "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": "20250401",
  "active_numerator_strength": "17"
}

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