Ursodiol
These highlights do not include all the information needed to use URSODIOL TABLETS safely and effectively. See full prescribing information for URSODIOL TABLETS. URSODIOL Tablets USP, for oral use Initial U.S. Approval: 1997
Approved
Approval ID
a3c98080-0a4d-4a93-8dcb-02ab8533050b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 8, 2023
Manufacturers
FDA
BluePoint Laboratories
DUNS: 985523874
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ursodiol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68001-377
Application NumberANDA090801
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ursodiol
Product Specifications
Route of AdministrationORAL
Effective DateMay 8, 2023
FDA Product Classification
INGREDIENTS (13)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
DIBUTYL SEBACATEInactive
Code: 4W5IH7FLNY
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
URSODIOLActive
Quantity: 250 mg in 1 1
Code: 724L30Y2QR
Classification: ACTIB
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
Ursodiol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68001-378
Application NumberANDA090801
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ursodiol
Product Specifications
Route of AdministrationORAL
Effective DateMay 8, 2023
FDA Product Classification
INGREDIENTS (13)
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
DIBUTYL SEBACATEInactive
Code: 4W5IH7FLNY
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
URSODIOLActive
Quantity: 500 mg in 1 1
Code: 724L30Y2QR
Classification: ACTIB
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT