🇺🇸
United States · US · US:10572-302_d21af010-592c-bd05-e053-2995a90a3d39
PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride
Orange BookUNIISPLATC C03CB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAffordable Pharmaceuticals, LLC
CountryUS (United States)
ATC codeC03CB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1110572302014 L in 1 BOTTLE (10572-302-01)
Annotations
UNII (FDA Substance ID)
G2M7P15E5P
POLYETHYLENE GLYCOL 3350
RxCUI 221147
Orange Book
N019797
AAAA
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": {
"cd9c0751-10fa-4f5f-bf29-742823541d22": {
"match": "brand_token",
"title": "PEG-3350, ELECTROLYTES, AND ASCORBATE (POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE, AND ASCORBIC ACID) KIT [OCEANSIDE PHARMACEUTICALS]",
"spl_version": "5",
"published_date": "2025-11-21"
}
},
"productid": "10572-302_d21af010-592c-bd05-e053-2995a90a3d39",
"productndc": "10572-302",
"dosage_form": "POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "019797",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AA",
"strength": "420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT",
"product_no": "001",
"approval_date": "Apr 22, 1991"
},
{
"rs": true,
"rld": true,
"te_code": "AA",
"strength": "420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT",
"product_no": "002",
"approval_date": "Nov 18, 1994"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE",
"proprietary_name": "PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride",
"active_ingred_unit": "g/4L; g/4L; g/4L; g/4L",
"application_number": "NDA019797",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride",
"start_marketing_date": "20130208",
"active_numerator_strength": "420; 1.48; 5.72; 11.2"
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