🇺🇸
United States · US · US:43386-050_3839c7fd-e7c4-45c6-ae02-0302b40046b0
GAVILYTE-N
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
- ndc114338605019438.4 g in 1 BOTTLE (43386-050-19)
Annotations
UNII (FDA Substance ID)
G2M7P15E5P
POLYETHYLENE GLYCOL 3350
RxCUI 221147
Orange Book
A090019
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": {
"27195187-75a3-431f-90d9-84da1b94e849": {
"match": "brand_token",
"title": "GAVILYTE-N (POLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATE) POWDER, FOR SOLUTION [LUPIN PHARMACEUTICALS,INC.]",
"spl_version": "7",
"published_date": "2025-09-12"
}
},
"productid": "43386-050_3839c7fd-e7c4-45c6-ae02-0302b40046b0",
"productndc": "43386-050",
"dosage_form": "POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "090019",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT",
"product_no": "001",
"approval_date": "May 27, 2009"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE",
"proprietary_name": "GAVILYTE-N",
"active_ingred_unit": "g/438.4g; g/438.4g; g/438.4g; g/438.4g",
"application_number": "ANDA090019",
"marketing_category": "ANDA",
"nonproprietary_name": "polyethylene glycol-3350, sodium chloride, potassium chloride and sodium bicarbonate",
"start_marketing_date": "20090528",
"active_numerator_strength": "420; 1.48; 5.72; 11.2"
}Related drugs
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