FDA.reportPublic FDA data

Avzivi

Product NDC
82143-002
11-digit product format
821430002
Labeler code
82143
Product ID
82143-002_3fff12d3-d86b-14e4-e063-6294a90a122e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bevacizumab-tnjn
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Bio-Thera Solutions, Ltd.
Application
BLA761198
Marketing category
BLA
Marketing start
2025-01-01
Substance
BEVACIZUMAB-TNJN
Active strength
400 mg/16mL
Pharmacologic classes
Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA], Vascular Endothelial Growth Factor-directed Antibody Interactions [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Avzivi
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BEVACIZUMAB-TNJN400 mg/16mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S9ZZM9Q9V
Rxcui2700735, 2700742, 2700744, 2700745

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
b8b10acb-0c88-4ff2-bdbd-3265dfc45b74Product name120241218
2b3a550b-5444-48ed-ac90-0bc9867c9e66Product name120170221
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82143-002-01Avzivi16 mL in 1 VIALINJECTION, SOLUTION164
82143-002-01Avzivi1 in 1 CARTONINJECTION, SOLUTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82143-002AVZIVI TNJN (BEVACIZUMAB) INJECTION, SOLUTION AVZIVI (BEVACIZUMAB-TNJN) INJECTION, SOLUTION [BIO-THERA SOLUTIONS, LTD.]3Current NDC, 2 package rows20250101_a3976cf9-9edb-4ca2-9375-9bcd2e32f5b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2700742Avzivi 100 MG in 4 ML InjectionPSNa3976cf9-9edb-4ca2-9375-9bcd2e32f5b44
2700745Avzivi 400 MG in 16 ML InjectionPSNa3976cf9-9edb-4ca2-9375-9bcd2e32f5b44
2700735bevacizumab-tnjn 100 MG in 4 ML InjectionPSNa3976cf9-9edb-4ca2-9375-9bcd2e32f5b44
2700744bevacizumab-tnjn 400 MG in 16 ML InjectionPSNa3976cf9-9edb-4ca2-9375-9bcd2e32f5b44
270074516 ML bevacizumab-tnjn 25 MG/ML Injection [Avzivi]SBDa3976cf9-9edb-4ca2-9375-9bcd2e32f5b44
27007424 ML bevacizumab-tnjn 25 MG/ML Injection [Avzivi]SBDa3976cf9-9edb-4ca2-9375-9bcd2e32f5b44
270074416 ML bevacizumab-tnjn 25 MG/ML InjectionSCDa3976cf9-9edb-4ca2-9375-9bcd2e32f5b44
27007354 ML bevacizumab-tnjn 25 MG/ML InjectionSCDa3976cf9-9edb-4ca2-9375-9bcd2e32f5b44
270074516 ML Avzivi 25 MG/ML InjectionSYa3976cf9-9edb-4ca2-9375-9bcd2e32f5b44
27007424 ML Avzivi 25 MG/ML InjectionSYa3976cf9-9edb-4ca2-9375-9bcd2e32f5b44
2700742Avzivi 100 MG per 4 ML InjectionSYa3976cf9-9edb-4ca2-9375-9bcd2e32f5b44
2700745Avzivi 400 MG per 16 ML InjectionSYa3976cf9-9edb-4ca2-9375-9bcd2e32f5b44
2700735bevacizumab-tnjn 100 MG per 4 ML InjectionSYa3976cf9-9edb-4ca2-9375-9bcd2e32f5b44
2700744bevacizumab-tnjn 400 MG per 16 ML InjectionSYa3976cf9-9edb-4ca2-9375-9bcd2e32f5b44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82143-002-01821430002011 VIAL in 1 CARTON (82143-002-01) / 16 mL in 1 VIAL1 vial2025-01-01NoNoHistorical