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United States · US · US:45802-868_1a88ad2b-b557-4991-aff2-a1f96159bbdc
Polyethylene Glycol 3350
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPadagis Israel Pharmaceuticals Ltd
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc114580286801119 g in 1 BOTTLE (45802-868-01)
- ndc114580286802238 g in 1 BOTTLE (45802-868-02)
- ndc114580286803510 g in 1 BOTTLE (45802-868-03)
- ndc11458028686614 PACKET in 1 CARTON (45802-868-66) / 17 g in 1 PACKET
Annotations
UNII (FDA Substance ID)
G2M7P15E5P
POLYETHYLENE GLYCOL 3350
RxCUI 221147
Orange Book
A090685
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": {
"ddc9d2b1-87d8-44fa-bac6-0a7261f33564": {
"match": "brand_token",
"title": "POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [MAJOR PHARMACEUTICALS]",
"spl_version": "11",
"published_date": "2026-05-25"
}
},
"productid": "45802-868_1a88ad2b-b557-4991-aff2-a1f96159bbdc",
"productndc": "45802-868",
"dosage_form": "POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "090685",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "17GM/PACKET",
"product_no": "001",
"approval_date": "Oct 6, 2009"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "17GM/SCOOPFUL",
"product_no": "002",
"approval_date": "Oct 6, 2009"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "POLYETHYLENE GLYCOL 3350",
"proprietary_name": "Polyethylene Glycol 3350",
"active_ingred_unit": "g/17g",
"application_number": "ANDA090685",
"marketing_category": "ANDA",
"nonproprietary_name": "Polyethylene Glycol 3350",
"start_marketing_date": "20091013",
"active_numerator_strength": "17"
}Access this data programmatically
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