MedPath

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

7945daa3-b607-48c3-a94f-f3a28b033dad

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 4, 2020

Manufacturers
FDA

Oceanside Pharmaceuticals

DUNS: 832011691

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

bexarotene

PRODUCT DETAILS

NDC Product Code68682-003
Application NumberNDA021055
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateApril 4, 2020
Generic Namebexarotene

INGREDIENTS (12)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
BEXAROTENEActive
Quantity: 75 mg in 1 1
Code: A61RXM4375
Classification: ACTIB
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
1,4-SORBITANInactive
Code: AV0YTZ4E6J
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
© Copyright 2025. All Rights Reserved by MedPath
bexarotene - FDA Approval | MedPath