Bexarotene
Bexarotene Capsules Rx Only These highlights do not include all the information needed to use BEXAROTENE CAPSULES safely and effectively. See full prescribing information for BEXAROTENE CAPSULES. Initial U.S. Approval: 1999
Approved
Approval ID
f9514265-6e2c-9030-e053-6394a90aa04b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 14, 2023
Manufacturers
FDA
AvKARE
DUNS: 796560394
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 Code42291-072
Application NumberANDA210105
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bexarotene
Product Specifications
Route of AdministrationORAL
Effective DateApril 14, 2023
FDA Product Classification
INGREDIENTS (17)
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITANInactive
Code: 6O92ICV9RU
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
BEXAROTENEActive
Quantity: 75 mg in 1 1
Code: A61RXM4375
Classification: ACTIB
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT