Xenical
These highlights do not include all the information needed to use XENICAL safely and effectively. See full prescribing information for XENICAL. XENICAL (orlistat) Capsules for oral use Initial U.S. Approval: 1999
Approved
Approval ID
6240792b-9224-2d10-e053-2a91aa0a2c3e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2023
Manufacturers
FDA
H2-Pharma LLC
DUNS: 028473634
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
orlistat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61269-460
Application NumberNDA020766
Product Classification
M
Marketing Category
C73594
G
Generic Name
orlistat
Product Specifications
Route of AdministrationORAL
Effective DateNovember 25, 2020
FDA Product Classification
INGREDIENTS (14)
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
ORLISTATActive
Quantity: 120 mg in 1 1
Code: 95M8R751W8
Classification: ACTIB