Targretin
These highlights do not include all the information needed to use TARGRETIN safely and effectively. See full prescribing information for TARGRETIN.TARGRETIN (bexarotene) capsules, for oral useInitial U.S. Approval: 1999
Approved
Approval ID
1d056725-0576-4338-8089-6336e768ccdc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 30, 2020
Manufacturers
FDA
Bausch Health US, LLC
DUNS: 831922468
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 Code0187-5526
Application NumberNDA021055
Product Classification
M
Marketing Category
C73594
G
Generic Name
bexarotene
Product Specifications
Route of AdministrationORAL
Effective DateApril 30, 2020
FDA Product Classification
INGREDIENTS (12)
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
BEXAROTENEActive
Quantity: 75 mg in 1 1
Code: A61RXM4375
Classification: ACTIB
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
1,4-SORBITANInactive
Code: AV0YTZ4E6J
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT