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 use Initial U.S. Approval: 2015
Approved
Approval ID
e5b67402-8550-4604-97a0-c7b149fbf753
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 13, 2023
Manufacturers
FDA
Manchester Pharmaceuticals, LLC
DUNS: 832417641
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 Code45043-001
Application NumberNDA205750
Product Classification
M
Marketing Category
C73594
G
Generic Name
Cholic Acid
Product Specifications
Route of AdministrationORAL
Effective DateMarch 13, 2023
FDA Product Classification
INGREDIENTS (7)
MAGNESIUM STEARATEInactive
Quantity: 0.8 mg in 1 1
Code: 70097M6I30
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
CHOLIC ACIDActive
Quantity: 50 mg in 1 1
Code: G1JO7801AE
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Quantity: 29.80 mg in 1 1
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Quantity: 3.4 mg in 1 1
Code: 2S7830E561
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 Code45043-002
Application NumberNDA205750
Product Classification
M
Marketing Category
C73594
G
Generic Name
Cholic Acid
Product Specifications
Route of AdministrationORAL
Effective DateMarch 13, 2023
FDA Product Classification
INGREDIENTS (6)
CHOLIC ACIDActive
Quantity: 250 mg in 1 1
Code: G1JO7801AE
Classification: ACTIB
MAGNESIUM STEARATEInactive
Quantity: 4.2 mg in 1 1
Code: 70097M6I30
Classification: IACT
CROSPOVIDONEInactive
Quantity: 16.80 mg in 1 1
Code: 2S7830E561
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Quantity: 149.02 mg in 1 1
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT