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United States · US · US:69557-222_25e07ab6-c140-6aae-e063-6394a90ac06e
Gloperba
Orange BookUNIISPLATC M04AC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerScilex Pharmaceuticals Inc.
CountryUS (United States)
ATC codeM04AC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1169557222011 BOTTLE in 1 CARTON (69557-222-01) / 150 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
SML2Y3J35T
COLCHICINE
RxCUI 2683
Orange Book
N210942
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "SML2Y3J35T",
"rxcui": "2683",
"inchikey": "IAKHMKGGTNLKSZ-INIZCTEOSA-N",
"display_name": "COLCHICINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"467cd83f-d695-4040-9434-10e80b4271da": {
"match": "brand_token",
"title": "GLOPERBA (COLCHICINE) SOLUTION [SCILEX PHARMACEUTICALS INC.]",
"spl_version": "3",
"published_date": "2024-11-05"
}
},
"productid": "69557-222_25e07ab6-c140-6aae-e063-6394a90ac06e",
"productndc": "69557-222",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "210942",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.6MG/5ML",
"product_no": "001",
"approval_date": "Jan 30, 2019"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "COLCHICINE",
"proprietary_name": "Gloperba",
"active_ingred_unit": "mg/5mL",
"application_number": "NDA210942",
"marketing_category": "NDA",
"nonproprietary_name": "Colchicine",
"start_marketing_date": "20240131",
"active_numerator_strength": ".6"
}Related drugs
Other records sharing ATC code M04AC01.
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