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United States · US · US:79378-002_edddbf7e-e2dd-4ff7-80a0-d73c22fd40ce
CHOLBAM
Orange BookUNIISPLATC A05AA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMirum Pharmaceuticals Inc.
CountryUS (United States)
ATC codeA05AA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11793780020290 CAPSULE in 1 BOTTLE (79378-002-02)
Annotations
UNII (FDA Substance ID)
G1JO7801AE
CHOLIC ACID
RxCUI 1440856
Orange Book
N205750
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "G1JO7801AE",
"rxcui": "1440856",
"inchikey": "BHQCQFFYRZLCQQ-OELDTZBJSA-N",
"display_name": "CHOLIC ACID",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"5c6e4c9d-b85e-493f-9420-ab2fd0ff3723": {
"match": "brand_token",
"title": "CHOLBAM (CHOLIC ACID) CAPSULE [MIRUM PHARMACEUTICALS INC.]",
"spl_version": "2",
"published_date": "2026-01-30"
}
},
"productid": "79378-002_edddbf7e-e2dd-4ff7-80a0-d73c22fd40ce",
"productndc": "79378-002",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "205750",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "50MG",
"product_no": "001",
"approval_date": "Mar 17, 2015"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "250MG",
"product_no": "002",
"approval_date": "Mar 17, 2015"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CHOLIC ACID",
"proprietary_name": "CHOLBAM",
"active_ingred_unit": "mg/1",
"application_number": "NDA205750",
"marketing_category": "NDA",
"nonproprietary_name": "cholic acid",
"start_marketing_date": "20250509",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code A05AA03.
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