🇺🇸
United States · US · US:0115-5211_4ec79132-daa8-4439-bbd2-6f8c8c020e4f
COLESTIPOL HYDROCHLORIDE
Orange BookUNIISPLATC C10AC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals of New York LLC
CountryUS (United States)
ATC codeC10AC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc110115521102500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-5211-02)
- ndc110115521116120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-5211-16)
Annotations
UNII (FDA Substance ID)
X7D10K905G
COLESTIPOL HYDROCHLORIDE
RxCUI 104485
Orange Book
A077510
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": "0115-5211_4ec79132-daa8-4439-bbd2-6f8c8c020e4f",
"productndc": "0115-5211",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "077510",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "1GM",
"product_no": "001",
"approval_date": "Oct 24, 2006"
}
],
"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": "ANDA077510",
"marketing_category": "ANDA",
"nonproprietary_name": "COLESTIPOL HYDROCHLORIDE",
"start_marketing_date": "20210817",
"active_numerator_strength": "1"
}Related drugs
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