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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72607-100
Application NumberNDA211723
Product Classification
M
Marketing Category
C73594
G
Generic Name
tazemetostat
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2023
FDA Product Classification
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