FDA.reportPublic FDA data

MVASI

Product NDC
55513-207
11-digit product format
555130207
Labeler code
55513
Product ID
55513-207_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
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
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
BEVACIZUMAB400 mg/16mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2S9ZZM9Q9VInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2046140Internal RxNorm lookup
2046145Internal RxNorm lookup
2046148Internal RxNorm lookup
2046149Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0a562b4e-67ce-4bab-852c-d9ee71e55fb8Available on FDA.report

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
55513-207-01MVASI1 in 1 CARTONINJECTION, SOLUTION122
55513-207-01MVASI16 mL in 1 VIALINJECTION, SOLUTION1622
55513-207-21MVASI1 in 1 CARTONINJECTION, SOLUTION122
55513-207-21MVASI16 mL in 1 VIALINJECTION, SOLUTION1622

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55513-207-01ML - Milliliter55513-2075498c66a-e30c-476b-afdb-3de5fcde598312019-08-06
55513-207-21ML - Milliliter55513-207744376be-7ecb-4034-9906-2a8a8edf3ffa12026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55513-207MVASI (BEVACIZUMAB-AWWB) INJECTION, SOLUTION [AMGEN INC]20Current NDC, Legacy NDC, 4 package rows20241114_0a562b4e-67ce-4bab-852c-d9ee71e55fb8.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MVASIBEVACIZUMAB-AWWBAmgen, Inc0a562b4e-67ce-4bab-852c-d9ee71e55fb82026-06-23Warnings, Adverse reactionsExact identifier
application number: BLA761028
ndc (product): 55513-207

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761028Mvasibevacizumab-awwb351(k) BiosimilarRx2026-07-01

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
55513-207-01555130207011 VIAL in 1 CARTON (55513-207-01) / 16 mL in 1 VIAL1 vial2018-06-010000-00-00NoNoCurrent
55513-207-21555130207211 VIAL in 1 CARTON (55513-207-21) / 16 mL in 1 VIAL1 vial2025-06-27NoNoCurrent