FDA.reportPublic FDA data

MVASI

Product NDC
55513-206
11-digit product format
555130206
Labeler code
55513
Product ID
55513-206_60b42908-21e6-4996-bfc9-d7f4589fa0b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bevacizumab-awwb
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Amgen, Inc
Application
BLA761028
Marketing category
BLA
Marketing start
2018-06-01
Substance
BEVACIZUMAB
Active strength
100 mg/4mL
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MVASI
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BEVACIZUMAB100 mg/4mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S9ZZM9Q9V
Rxcui2046140, 2046145, 2046148, 2046149

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
55513-206-01MVASI4 mL in 1 VIALINJECTION, SOLUTION422
55513-206-01MVASI1 in 1 CARTONINJECTION, SOLUTION122
55513-206-21MVASI4 mL in 1 VIALINJECTION, SOLUTION422
55513-206-21MVASI1 in 1 CARTONINJECTION, SOLUTION122

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55513-206-01ML - Milliliter55513-20611775009-ef69-4371-a33f-6220097d9bae12019-08-06
55513-206-21ML - Milliliter55513-2065738e1c8-7857-4f4d-8c64-8d56dca311b812026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55513-206MVASI (BEVACIZUMAB-AWWB) INJECTION, SOLUTION [AMGEN INC]20Current NDC, Legacy NDC, 4 package rows20241114_0a562b4e-67ce-4bab-852c-d9ee71e55fb8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2046148bevacizumab-awwb 100 MG in 4 ML InjectionPSN0a562b4e-67ce-4bab-852c-d9ee71e55fb822
2046140bevacizumab-awwb 400 MG in 16 ML InjectionPSN0a562b4e-67ce-4bab-852c-d9ee71e55fb822
2046149MVASI 100 MG in 4 ML InjectionPSN0a562b4e-67ce-4bab-852c-d9ee71e55fb822
2046145MVASI 400 MG in 16 ML InjectionPSN0a562b4e-67ce-4bab-852c-d9ee71e55fb822
204614516 ML bevacizumab-awwb 25 MG/ML Injection [Mvasi]SBD0a562b4e-67ce-4bab-852c-d9ee71e55fb822
20461494 ML bevacizumab-awwb 25 MG/ML Injection [Mvasi]SBD0a562b4e-67ce-4bab-852c-d9ee71e55fb822
204614016 ML bevacizumab-awwb 25 MG/ML InjectionSCD0a562b4e-67ce-4bab-852c-d9ee71e55fb822
20461484 ML bevacizumab-awwb 25 MG/ML InjectionSCD0a562b4e-67ce-4bab-852c-d9ee71e55fb822
204614516 ML Mvasi 25 MG/ML InjectionSY0a562b4e-67ce-4bab-852c-d9ee71e55fb822
20461494 ML Mvasi 25 MG/ML InjectionSY0a562b4e-67ce-4bab-852c-d9ee71e55fb822
2046148bevacizumab-awwb 100 MG per 4 ML InjectionSY0a562b4e-67ce-4bab-852c-d9ee71e55fb822
2046140bevacizumab-awwb 400 MG per 16 ML InjectionSY0a562b4e-67ce-4bab-852c-d9ee71e55fb822
2046149Mvasi 100 MG per 4 ML InjectionSY0a562b4e-67ce-4bab-852c-d9ee71e55fb822
2046145Mvasi 400 MG per 16 ML InjectionSY0a562b4e-67ce-4bab-852c-d9ee71e55fb822

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55513-206-01555130206011 VIAL in 1 CARTON (55513-206-01) / 4 mL in 1 VIAL1 vial2018-06-010000-00-00NoNoCurrent
55513-206-21555130206211 VIAL in 1 CARTON (55513-206-21) / 4 mL in 1 VIAL1 vial2025-06-27NoNoHistorical