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United States · US · US:0713-0879_285004c5-f33a-aaa1-e063-6394a90aac01
Welchol
Orange BookUNIISPLATC C10AC04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCosette Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeC10AC04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110713087981180 TABLET, FILM COATED in 1 BOTTLE (0713-0879-81)
Annotations
UNII (FDA Substance ID)
P4SG24WI5Q
COLESEVELAM HYDROCHLORIDE
RxCUI 141625
Orange Book
N021176
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "P4SG24WI5Q",
"rxcui": "141625",
"inchikey": null,
"display_name": "COLESEVELAM HYDROCHLORIDE",
"substance_type": "polymer",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"89cbd0a3-2d1b-41db-8c97-35ec67b7b09f": {
"match": "brand_token",
"title": "WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [COSETTE PHARMACEUTICALS, INC.]",
"spl_version": "3",
"published_date": "2024-12-04"
}
},
"productid": "0713-0879_285004c5-f33a-aaa1-e063-6394a90aac01",
"productndc": "0713-0879",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "021176",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "625MG",
"product_no": "001",
"approval_date": "May 26, 2000"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "COLESEVELAM HYDROCHLORIDE",
"proprietary_name": "Welchol",
"active_ingred_unit": "mg/1",
"application_number": "NDA021176",
"marketing_category": "NDA",
"nonproprietary_name": "colesevelam hydrochloride",
"start_marketing_date": "20220901",
"active_numerator_strength": "625"
}Related drugs
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