Bexarotene
These highlights do not include all the information needed to use BEXAROTENE CAPSULES safely and effectively. See full prescribing information for BEXAROTENE CAPSULES.BEXAROTENE capsules, for oral useInitial U.S. Approval: 1999
Approved
Approval ID
dc8d68d1-0c5c-4004-b71d-22b83daf4270
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 13, 2020
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 080189610
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
bexarotene
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0054-0399
Application NumberANDA203663
Product Classification
M
Marketing Category
C73584
G
Generic Name
bexarotene
Product Specifications
Route of AdministrationORAL
Effective DateNovember 11, 2020
FDA Product Classification
INGREDIENTS (16)
BEXAROTENEActive
Quantity: 75 mg in 1 1
Code: A61RXM4375
Classification: ACTIB
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
SORBITANInactive
Code: 6O92ICV9RU
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT