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United States · US · US:76420-489_411a7a72-348c-4e5b-e063-6294a90a6c7e
MiraLAX
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerASCLEMED USA INC.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc11764204891010 PACKET in 1 CARTON (76420-489-10) / 17 g in 1 PACKET
- ndc11764204892020 POUCH in 1 CARTON (76420-489-20) / 17 g in 1 POUCH
- ndc11764204892424 PACKET in 1 CARTON (76420-489-24) / 17 g in 1 PACKET
- ndc117642048977765 g in 1 BOTTLE, PLASTIC (76420-489-77)
- ndc117642048985850 g in 1 BOTTLE, PLASTIC (76420-489-85)
Annotations
UNII (FDA Substance ID)
G2M7P15E5P
POLYETHYLENE GLYCOL 3350
RxCUI 221147
Orange Book
N022015
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": {
"d69ce3d4-7ca4-4fe3-b49e-6655e48d6963": {
"match": "brand_token",
"title": "MIRALAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [BAYER HEALTHCARE LLC.]",
"spl_version": "24",
"published_date": "2026-05-06"
}
},
"productid": "76420-489_411a7a72-348c-4e5b-e063-6294a90a6c7e",
"productndc": "76420-489",
"dosage_form": "POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "022015",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "17GM/SCOOPFUL",
"product_no": "001",
"approval_date": "Oct 6, 2006"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "17GM/PACKET",
"product_no": "002",
"approval_date": "Oct 6, 2006"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "POLYETHYLENE GLYCOL 3350",
"proprietary_name": "MiraLAX",
"active_ingred_unit": "g/17g",
"application_number": "NDA022015",
"marketing_category": "NDA",
"nonproprietary_name": "Polyethylene Glycol 3350",
"start_marketing_date": "20070201",
"active_numerator_strength": "17"
}Access this data programmatically
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