🇺🇸
United States · US · US:62559-395_f062e9d4-c5ef-411e-8f4a-6deec3ee95c7
COLESTIPOL HYDROCHLORIDE
Orange BookUNIISPLATC C10AC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeC10AC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116255939512120 TABLET, FILM COATED in 1 BOTTLE (62559-395-12)
Annotations
UNII (FDA Substance ID)
X7D10K905G
COLESTIPOL HYDROCHLORIDE
RxCUI 104485
Orange Book
A216517
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "X7D10K905G",
"rxcui": "104485",
"inchikey": null,
"display_name": "COLESTIPOL HYDROCHLORIDE",
"substance_type": "polymer",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"153e9154-1804-4d73-94b7-a31a1d37c420": {
"match": "brand_token",
"title": "COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]",
"spl_version": "5",
"published_date": "2025-11-17"
}
},
"productid": "62559-395_f062e9d4-c5ef-411e-8f4a-6deec3ee95c7",
"productndc": "62559-395",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "216517",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1GM",
"product_no": "001",
"approval_date": "Mar 10, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "COLESTIPOL HYDROCHLORIDE",
"proprietary_name": "COLESTIPOL HYDROCHLORIDE",
"active_ingred_unit": "g/1",
"application_number": "ANDA216517",
"marketing_category": "ANDA",
"nonproprietary_name": "COLESTIPOL HYDROCHLORIDE",
"start_marketing_date": "20230515",
"active_numerator_strength": "1"
}Related drugs
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