TAZVERIK
These highlights do not include all the information needed to use TAZVERIK safely and effectively. See full prescribing information for TAZVERIK. TAZVERIK (tazemetostat) tablets, for oral useInitial U.S. Approval: 2020
Approved
Approval ID
7db07b5f-4e22-467c-9c0a-f830b08dbb1d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2023
Manufacturers
FDA
Epizyme, Inc.
DUNS: 018795119
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
tazemetostat
PRODUCT DETAILS
NDC Product Code72607-100
Application NumberNDA211723
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateDecember 21, 2023
Generic Nametazemetostat
INGREDIENTS (11)
tazemetostat hydrobromideActive
Quantity: 200 mg in 1 1
Code: 6P89T5M073
Classification: ACTIM
Lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Low-substituted hydroxypropyl cellulose, unspecifiedInactive
Code: 2165RE0K14
Classification: IACT
Hydroxypropyl cellulose, unspecifiedInactive
Code: 9XZ8H6N6OH
Classification: IACT
Sodium starch glycolate Type A potatoInactive
Code: 5856J3G2A2
Classification: IACT
Magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
Hypromellose, unspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Polyethylene glycol 8000Inactive
Code: Q662QK8M3B
Classification: IACT
Titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT