GAVILAX

Orange BookUNIISPL

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009053100
238 g in 1 BOTTLE (50090-5310-0)

Annotations

UNII (FDA Substance ID)

G2M7P15E5P

POLYETHYLENE GLYCOL 3350

RxCUI 221147

Orange Book

A091077

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": {
    "21654def-5ae0-422d-961b-1fe2456af00a": {
      "match": "brand_token",
      "title": "GAVILAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [PREFERRED PHARMACEUTICALS, INC.]",
      "spl_version": "7",
      "published_date": "2026-05-06"
    }
  },
  "productid": "50090-5310_9d13eb45-0bd9-4756-b8c4-7cd2b79ad5f7",
  "productndc": "50090-5310",
  "dosage_form": "POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "091077",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "17GM/SCOOPFUL",
        "product_no": "001",
        "approval_date": "Oct 6, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "17GM/PACKET",
        "product_no": "002",
        "approval_date": "Jun 27, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "POLYETHYLENE GLYCOL 3350",
  "proprietary_name": "GAVILAX",
  "active_ingred_unit": "g/17g",
  "application_number": "ANDA091077",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Polyethylene Glycol 3350",
  "start_marketing_date": "20091009",
  "active_numerator_strength": "17"
}

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