Ocaliva
These highlights do not include all the information needed to use OCALIVA safely and effectively. See full prescribing information for OCALIVA. OCALIVA (obeticholic acid) tablets, for oral use Initial U.S. Approval: 2016
Approved
Approval ID
cdfbe0cd-eb15-45a1-ac17-531bcda21aec
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 18, 2022
Manufacturers
FDA
Intercept Pharmaceuticals Inc
DUNS: 966658416
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Obeticholic Acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69516-010
Application NumberNDA207999
Product Classification
M
Marketing Category
C73594
G
Generic Name
Obeticholic Acid
Product Specifications
Route of AdministrationORAL
Effective DateOctober 18, 2022
FDA Product Classification
INGREDIENTS (9)
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
OBETICHOLIC ACIDActive
Quantity: 10 mg in 1 1
Code: 0462Z4S4OZ
Classification: ACTIB
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Obeticholic Acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69516-005
Application NumberNDA207999
Product Classification
M
Marketing Category
C73594
G
Generic Name
Obeticholic Acid
Product Specifications
Route of AdministrationORAL
Effective DateOctober 18, 2022
FDA Product Classification
INGREDIENTS (9)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
OBETICHOLIC ACIDActive
Quantity: 5 mg in 1 1
Code: 0462Z4S4OZ
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT