Bexarotene
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 1999
Approved
Approval ID
2d1eb4bd-51f9-4c9b-9fb1-0be5e30a3dc5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 13, 2018
Manufacturers
FDA
Mylan Pharmaceuticals Inc.
DUNS: 059295980
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 Code0378-6955
Application NumberANDA203174
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bexarotene
Product Specifications
Route of AdministrationORAL
Effective DateJune 14, 2017
FDA Product Classification
INGREDIENTS (12)
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
BEXAROTENEActive
Quantity: 75 mg in 1 1
Code: A61RXM4375
Classification: ACTIB
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT