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United States · US · US:67877-506_6289ed62-26fb-4c9e-971a-39a5e53c5c2e
Colesevelam HCL
Orange BookUNIISPLATC C10AC04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAscend Laboratories, LLC
CountryUS (United States)
ATC codeC10AC04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc116787750605500 TABLET, FILM COATED in 1 BOTTLE (67877-506-05)
- ndc11678775063030 TABLET, FILM COATED in 1 BOTTLE (67877-506-30)
- ndc116787750651180 TABLET, FILM COATED in 1 BOTTLE (67877-506-51)
- ndc11678775069090 TABLET, FILM COATED in 1 BOTTLE (67877-506-90)
Annotations
UNII (FDA Substance ID)
P4SG24WI5Q
COLESEVELAM HYDROCHLORIDE
RxCUI 141625
Orange Book
A209038
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": {
"dbed6967-b261-44a1-bee4-638810e2efe9": {
"match": "brand_token",
"title": "COLESEVELAM HYDROCHLORIDE POWDER, FOR SUSPENSION [BRYANT RANCH PREPACK]",
"spl_version": "103",
"published_date": "2026-05-28"
}
},
"productid": "67877-506_6289ed62-26fb-4c9e-971a-39a5e53c5c2e",
"productndc": "67877-506",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "209038",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "625MG",
"product_no": "001",
"approval_date": "Oct 5, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "COLESEVELAM HYDROCHLORIDE",
"proprietary_name": "Colesevelam HCL",
"active_ingred_unit": "mg/1",
"application_number": "ANDA209038",
"marketing_category": "ANDA",
"nonproprietary_name": "Colesevelam HCL",
"start_marketing_date": "20181006",
"active_numerator_strength": "625"
}Related drugs
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