MedPath

TRIZIVIR

These highlights do not include all the information needed to use TRIZIVIR safely and effectively. See full prescribing information for TRIZIVIR. TRIZIVIR (abacavir sulfate, lamivudine, and zidovudine) Tablets, for oral useInitial U.S. Approval: 2000

Approved
Approval ID

3354e50f-4dc5-413f-b5ae-87353ab8913d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 24, 2014

Manufacturers
FDA

State of Florida DOH Central Pharmacy

DUNS: 829348114

Products 1

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

abacavir sulfate, lamivudine, and zidovudine

PRODUCT DETAILS

NDC Product Code53808-0990
Application NumberNDA021205
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateApril 24, 2014
Generic Nameabacavir sulfate, lamivudine, and zidovudine

INGREDIENTS (11)

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
ABACAVIR SULFATEActive
Quantity: 300 mg in 1 1
Code: J220T4J9Q2
Classification: ACTIM
LAMIVUDINEActive
Quantity: 150 mg in 1 1
Code: 2T8Q726O95
Classification: ACTIB
ZIDOVUDINEActive
Quantity: 300 mg in 1 1
Code: 4B9XT59T7S
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

TRIZIVIR - FDA Drug Approval Details