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United States · US · US:43386-312_ced29c35-5d51-4eb1-8119-1c988d29a592
GAVILAX
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLupin Pharmaceuticals,Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc114338631208238 g in 1 BOTTLE (43386-312-08)
- ndc114338631214510 g in 1 BOTTLE (43386-312-14)
Annotations
UNII (FDA Substance ID)
G2M7P15E5P
POLYETHYLENE GLYCOL 3350
RxCUI 221147
Orange Book
A091077
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": {
"21654def-5ae0-422d-961b-1fe2456af00a": {
"match": "brand_token",
"title": "GAVILAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [PREFERRED PHARMACEUTICALS, INC.]",
"spl_version": "7",
"published_date": "2026-05-06"
}
},
"productid": "43386-312_ced29c35-5d51-4eb1-8119-1c988d29a592",
"productndc": "43386-312",
"dosage_form": "POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "091077",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "17GM/SCOOPFUL",
"product_no": "001",
"approval_date": "Oct 6, 2009"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "17GM/PACKET",
"product_no": "002",
"approval_date": "Jun 27, 2011"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "POLYETHYLENE GLYCOL 3350",
"proprietary_name": "GAVILAX",
"active_ingred_unit": "g/17g",
"application_number": "ANDA091077",
"marketing_category": "ANDA",
"nonproprietary_name": "Polyethylene Glycol 3350",
"start_marketing_date": "20091009",
"active_numerator_strength": "17"
}Access this data programmatically
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