CHOLBAM
These highlights do not include all the information needed to use CHOLBAM safely and effectively. See full prescribing information for CHOLBAM. CHOLBAM (cholic acid) capsules, for oral useInitial U.S. Approval: 2015
Approved
Approval ID
5c6e4c9d-b85e-493f-9420-ab2fd0ff3723
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 9, 2025
Manufacturers
FDA
Mirum Pharmaceuticals Inc.
DUNS: 116902386
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
cholic acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code79378-001
Application NumberNDA205750
Product Classification
M
Marketing Category
C73594
G
Generic Name
cholic acid
Product Specifications
Route of AdministrationORAL
Effective DateMay 9, 2025
FDA Product Classification
INGREDIENTS (7)
CHOLIC ACIDActive
Quantity: 50 mg in 1 1
Code: G1JO7801AE
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
cholic acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code79378-002
Application NumberNDA205750
Product Classification
M
Marketing Category
C73594
G
Generic Name
cholic acid
Product Specifications
Route of AdministrationORAL
Effective DateMay 9, 2025
FDA Product Classification
INGREDIENTS (6)
CHOLIC ACIDActive
Quantity: 250 mg in 1 1
Code: G1JO7801AE
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT