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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
- ndc1152268100014 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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