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United States · US · US:52268-100_c3649858-77b7-2295-e053-2995a90a048f

GoLYTELY

Orange BookUNIISPLATC C03CB

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

Identification

ManufacturerBraintree Laboratories, Inc.
CountryUS (United States)
ATC codeC03CB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5226810001
    4 L in 1 BOTTLE, PLASTIC (52268-100-01)

Annotations

UNII (FDA Substance ID)
G2M7P15E5P
POLYETHYLENE GLYCOL 3350
RxCUI 221147
Orange Book
N019011
AA
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": {
    "7609ecf7-0ce0-4fbb-9c27-30987f689575": {
      "match": "brand_token",
      "title": "GOLYTELY (POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE) POWDER, FOR SOLUTION [AZURITY PHARMACEUTICALS, INC.]",
      "spl_version": "1",
      "published_date": "2026-04-23"
    }
  },
  "productid": "52268-100_c3649858-77b7-2295-e053-2995a90a048f",
  "productndc": "52268-100",
  "dosage_form": "POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "019011",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AA",
        "strength": "236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT",
        "product_no": "001",
        "approval_date": "Jul 13, 1984"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET",
        "product_no": "002",
        "approval_date": "Jun 2, 1992"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS",
  "proprietary_name": "GoLYTELY",
  "active_ingred_unit": "g/4L; g/4L; g/4L; g/4L; g/4L",
  "application_number": "NDA019011",
  "marketing_category": "NDA",
  "nonproprietary_name": "Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride",
  "start_marketing_date": "19840713",
  "active_numerator_strength": "236; 2.97; 6.74; 5.86; 22.74"
}

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