Back to search
🇺🇸

United States · US · US:43386-060_5105b61a-4ca7-4096-9cd0-cf22f46ffaf8

GaviLyte - C

Orange BookUNIISPLATC C03CB

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

Identification

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

Packs · 1

  • ndc11
    4338606019
    278.26 g in 1 BOTTLE (43386-060-19)

Annotations

UNII (FDA Substance ID)
G2M7P15E5P
POLYETHYLENE GLYCOL 3350
RxCUI 221147
Orange Book
A090186
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": {
    "3978822b-6473-4072-9f80-20ceb9bea355": {
      "match": "brand_token",
      "title": "GAVILYTE G TM (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES) POWDER, FOR SOLUTION [LUPIN PHARMACEUTICALS,INC.]",
      "spl_version": "9",
      "published_date": "2025-09-15"
    }
  },
  "productid": "43386-060_5105b61a-4ca7-4096-9cd0-cf22f46ffaf8",
  "productndc": "43386-060",
  "dosage_form": "POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "090186",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT",
        "product_no": "001",
        "approval_date": "Jun 1, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS",
  "proprietary_name": "GaviLyte - C",
  "active_ingred_unit": "g/278.26g; g/278.26g; g/278.26g; g/278.26g; g/278.26g",
  "application_number": "ANDA090186",
  "marketing_category": "ANDA",
  "nonproprietary_name": "polyethylene glycol-3350 and electrolytes with Flavor Pack",
  "start_marketing_date": "20090106",
  "active_numerator_strength": "240; 2.98; 6.72; 5.84; 22.72"
}

Related drugs

Other records sharing ATC code C03CB.

Access this data programmatically

Query GaviLyte - C 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.