Back to search
🇺🇸

United States · US · US:45861-083_2f83c954-31c2-fa95-e063-6394a90a5861

Polyethylene Glycol 3350, NF Powder for Solution, Laxative

Orange BookUNIISPL

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

Identification

ManufacturerPharmaceutica North America, Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4586108305
    238 d in 1 BOTTLE (45861-083-05)
  • ndc11
    4586108306
    2 BOTTLE in 1 BOX (45861-083-06) / 476 d in 1 BOTTLE

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": "45861-083_2f83c954-31c2-fa95-e063-6394a90a5861",
  "productndc": "45861-083",
  "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": "20250210",
  "active_numerator_strength": "17"
}

Access this data programmatically

Query Polyethylene Glycol 3350, NF Powder for Solution, Laxative and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.