FDA.reportPublic FDA data

Zirabev

Product NDC
0069-0342
11-digit product format
000690342
Labeler code
0069
Product ID
0069-0342_3135aec5-1b5d-4de4-9b73-bfeb7821b75d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bevacizumab-bvzr
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
BLA761099
Marketing category
BLA
Marketing start
2020-01-13
Substance
BEVACIZUMAB
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
Zirabev
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BEVACIZUMAB400 mg/16mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S9ZZM9Q9V
Rxcui2268039, 2268044, 2268047, 2268048

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b8b10acb-0c88-4ff2-bdbd-3265dfc45b74Product name120241218
2b3a550b-5444-48ed-ac90-0bc9867c9e66Product name120170221

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0069-0342-01Zirabev1 in 1 CARTONINJECTION, SOLUTION112
0069-0342-01Zirabev16 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION1612

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-0342-01ML - Milliliter0069-0342288f50ca-28da-4285-8472-f0ede57b5eee12020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-0342ZIRABEV (BEVACIZUMAB-BVZR) INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]11Current NDC, Legacy NDC, 2 package rows20250124_aa27acbd-d117-4350-aeee-17bc2e2c0ca4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2268039bevacizumab-bvzr 100 MG in 4 ML InjectionPSNaa27acbd-d117-4350-aeee-17bc2e2c0ca412
2268047bevacizumab-bvzr 400 MG in 16 ML InjectionPSNaa27acbd-d117-4350-aeee-17bc2e2c0ca412
2268044Zirabev 100 MG in 4 ML InjectionPSNaa27acbd-d117-4350-aeee-17bc2e2c0ca412
2268048Zirabev 400 MG in 16 ML InjectionPSNaa27acbd-d117-4350-aeee-17bc2e2c0ca412
226804816 ML bevacizumab-bvzr 25 MG/ML Injection [Zirabev]SBDaa27acbd-d117-4350-aeee-17bc2e2c0ca412
22680444 ML bevacizumab-bvzr 25 MG/ML Injection [Zirabev]SBDaa27acbd-d117-4350-aeee-17bc2e2c0ca412
226804716 ML bevacizumab-bvzr 25 MG/ML InjectionSCDaa27acbd-d117-4350-aeee-17bc2e2c0ca412
22680394 ML bevacizumab-bvzr 25 MG/ML InjectionSCDaa27acbd-d117-4350-aeee-17bc2e2c0ca412
2268039bevacizumab-bvzr 100 MG per 4 ML InjectionSYaa27acbd-d117-4350-aeee-17bc2e2c0ca412
2268047bevacizumab-bvzr 25 MG/ML per 16 ML InjectionSYaa27acbd-d117-4350-aeee-17bc2e2c0ca412
2268039bevacizumab-bvzr 25 MG/ML per 4 ML InjectionSYaa27acbd-d117-4350-aeee-17bc2e2c0ca412
2268047bevacizumab-bvzr 400 MG per 16 ML InjectionSYaa27acbd-d117-4350-aeee-17bc2e2c0ca412
2268044Zirabev 100 MG per 4 ML InjectionSYaa27acbd-d117-4350-aeee-17bc2e2c0ca412
2268048Zirabev 25 MG/ML per 16 ML InjectionSYaa27acbd-d117-4350-aeee-17bc2e2c0ca412
2268044Zirabev 25 MG/ML per 4 ML InjectionSYaa27acbd-d117-4350-aeee-17bc2e2c0ca412
2268048Zirabev 400 MG per 16 ML InjectionSYaa27acbd-d117-4350-aeee-17bc2e2c0ca412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0069-0342-01000690342011 VIAL, SINGLE-USE in 1 CARTON (0069-0342-01) / 16 mL in 1 VIAL, SINGLE-USE2020-01-130000-00-00NoNoCurrent