rugby PEG 3350

Orange BookUNIISPL

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

Identification

ManufacturerRugby Laboratories

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
0536105224
238 g in 1 BOTTLE (0536-1052-24)
ndc11
0536105227
510 g in 1 BOTTLE (0536-1052-27)
ndc11
0536105260
119 g in 1 BOTTLE (0536-1052-60)
ndc11
0536105284
850 g in 1 BOTTLE (0536-1052-84)

Annotations

UNII (FDA Substance ID)

G2M7P15E5P

POLYETHYLENE GLYCOL 3350

RxCUI 221147

Orange Book

A090685

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": {
    "50c46cf5-3e64-9e0f-e063-6294a90a2317": {
      "match": "brand_token",
      "title": "RUGBY ANTIFUNGAL (TOLNAFTATE AEROSOL, POWDER) AEROSOL, SPRAY [RUGBY LABORATORIES]",
      "spl_version": "2",
      "published_date": "2026-05-20"
    }
  },
  "productid": "0536-1052_6eba58d0-ed5a-4118-a049-c28c5dd9a4b1",
  "productndc": "0536-1052",
  "dosage_form": "POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "090685",
    "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 3350",
  "proprietary_name": "rugby PEG 3350",
  "active_ingred_unit": "g/17g",
  "application_number": "ANDA090685",
  "marketing_category": "ANDA",
  "nonproprietary_name": "POLYETHYLENE GLYCOL 3350",
  "start_marketing_date": "20150105",
  "active_numerator_strength": "17"
}

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