FDA.reportPublic FDA data

Vegzelma

Product NDC
72606-012
11-digit product format
726060012
Labeler code
72606
Product ID
72606-012_46db7808-58a2-4ec9-aa54-17c2602da528
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bevacizumab-adcd
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
CELLTRION USA, Inc.
Application
BLA761268
Marketing category
BLA
Marketing start
2023-04-03
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
Vegzelma
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BEVACIZUMAB400 mg/16mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S9ZZM9Q9V
Rxcui2627650, 2627656, 2627658, 2627659

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
72606-012-01Vegzelma16 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION164
72606-012-01Vegzelma1 in 1 CARTONINJECTION, SOLUTION14
72606-012-10Vegzelma16 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION164
72606-012-10Vegzelma10 in 1 CARTONINJECTION, SOLUTION104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72606-012VEGZELMA (BEVACIZUMAB-ADCD) INJECTION, SOLUTION [CELLTRION USA, INC.]4Current NDC, 4 package rows20250510_4cdcccda-7b9a-49d0-ac50-f4605a3c0ebe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2627650bevacizumab-adcd 100 MG in 4 ML InjectionPSN4cdcccda-7b9a-49d0-ac50-f4605a3c0ebe4
2627658bevacizumab-adcd 400 MG in 16 ML InjectionPSN4cdcccda-7b9a-49d0-ac50-f4605a3c0ebe4
2627656Vegzelma 100 MG in 4 ML InjectionPSN4cdcccda-7b9a-49d0-ac50-f4605a3c0ebe4
2627659Vegzelma 400 MG in 16 ML InjectionPSN4cdcccda-7b9a-49d0-ac50-f4605a3c0ebe4
262765916 ML bevacizumab-adcd 25 MG/ML Injection [Vegzelma]SBD4cdcccda-7b9a-49d0-ac50-f4605a3c0ebe4
26276564 ML bevacizumab-adcd 25 MG/ML Injection [Vegzelma]SBD4cdcccda-7b9a-49d0-ac50-f4605a3c0ebe4
262765816 ML bevacizumab-adcd 25 MG/ML InjectionSCD4cdcccda-7b9a-49d0-ac50-f4605a3c0ebe4
26276504 ML bevacizumab-adcd 25 MG/ML InjectionSCD4cdcccda-7b9a-49d0-ac50-f4605a3c0ebe4
262765916 ML Vegzelma 25 MG/ML InjectionSY4cdcccda-7b9a-49d0-ac50-f4605a3c0ebe4
26276564 ML Vegzelma 25 MG/ML InjectionSY4cdcccda-7b9a-49d0-ac50-f4605a3c0ebe4
2627650bevacizumab-adcd 100 MG per 4 ML InjectionSY4cdcccda-7b9a-49d0-ac50-f4605a3c0ebe4
2627658bevacizumab-adcd 400 MG per 16 ML InjectionSY4cdcccda-7b9a-49d0-ac50-f4605a3c0ebe4
2627656Vegzelma 100 MG per 4 ML InjectionSY4cdcccda-7b9a-49d0-ac50-f4605a3c0ebe4
2627659Vegzelma 400 MG per 16 ML InjectionSY4cdcccda-7b9a-49d0-ac50-f4605a3c0ebe4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72606-012-01726060012011 VIAL, SINGLE-USE in 1 CARTON (72606-012-01) / 16 mL in 1 VIAL, SINGLE-USE2023-04-03NoNoCurrent
72606-012-107260600121010 VIAL, SINGLE-USE in 1 CARTON (72606-012-10) / 16 mL in 1 VIAL, SINGLE-USE2023-04-03NoNoCurrent