FDA.reportPublic FDA data

ALYMSYS

Product NDC
85006-1755
11-digit product format
850061755
Labeler code
85006
Product ID
85006-1755_25c471d4-a4c1-4f99-8848-c49ce5b0000a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bevacizumab-maly
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Valorum Biologics, LLC
Application
BLA761231
Marketing category
BLA
Marketing start
2026-03-30
Substance
BEVACIZUMAB-MALY
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
ALYMSYS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BEVACIZUMAB-MALY400 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
2599043Internal RxNorm lookup
2599049Internal RxNorm lookup
2599051Internal RxNorm lookup
2599052Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
42b4f96e-1f70-2126-e063-6294a90a93e3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85006-1755-1ALYMSYS16 mL in 1 VIALINJECTION, SOLUTION167
85006-1755-1ALYMSYS1 in 1 CARTONINJECTION, SOLUTION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85006-1755-1ML - Milliliter85006-1755740db22d-7c93-4fb1-a8f0-d0c3b1bbb17a12026-04-20

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALYMSYSBEVACIZUMAB-MALYAmneal Pharmaceuticals LLC6b4040a2-a5c5-4ff0-ab45-935d7e49cf782026-03-23Warnings, Adverse reactionsExact identifier
application number: BLA761231
ALYMSYSBEVACIZUMAB-MALYValorum Biologics, LLC42b4f96e-1f70-2126-e063-6294a90a93e32026-01-27Warnings, Adverse reactionsExact identifier
application number: BLA761231
ndc (product): 85006-1755

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761231Alymsysbevacizumab-maly351(k) BiosimilarRx2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2599049Alymsys 100 MG in 4 ML InjectionPSN42b4f96e-1f70-2126-e063-6294a90a93e37
2599052Alymsys 400 MG in 16 ML InjectionPSN42b4f96e-1f70-2126-e063-6294a90a93e37
2599043bevacizumab-maly 100 MG in 4 ML InjectionPSN42b4f96e-1f70-2126-e063-6294a90a93e37
2599051bevacizumab-maly 400 MG in 16 ML InjectionPSN42b4f96e-1f70-2126-e063-6294a90a93e37
259905216 ML bevacizumab-maly 25 MG/ML Injection [Alymsys]SBD42b4f96e-1f70-2126-e063-6294a90a93e37
25990494 ML bevacizumab-maly 25 MG/ML Injection [Alymsys]SBD42b4f96e-1f70-2126-e063-6294a90a93e37
259905116 ML bevacizumab-maly 25 MG/ML InjectionSCD42b4f96e-1f70-2126-e063-6294a90a93e37
25990434 ML bevacizumab-maly 25 MG/ML InjectionSCD42b4f96e-1f70-2126-e063-6294a90a93e37
2599049Alymsys 100 MG per 4 ML InjectionSY42b4f96e-1f70-2126-e063-6294a90a93e37
2599052Alymsys 25 MG/ML per 16 ML InjectionSY42b4f96e-1f70-2126-e063-6294a90a93e37
2599049Alymsys 25 MG/ML per 4 ML InjectionSY42b4f96e-1f70-2126-e063-6294a90a93e37
2599052Alymsys 400 MG per 16 ML InjectionSY42b4f96e-1f70-2126-e063-6294a90a93e37
2599043bevacizumab-maly 100 MG per 4 ML InjectionSY42b4f96e-1f70-2126-e063-6294a90a93e37
2599051bevacizumab-maly 25 MG/ML per 16 ML InjectionSY42b4f96e-1f70-2126-e063-6294a90a93e37
2599043bevacizumab-maly 25 MG/ML per 4 ML InjectionSY42b4f96e-1f70-2126-e063-6294a90a93e37
2599051bevacizumab-maly 400 MG per 16 ML InjectionSY42b4f96e-1f70-2126-e063-6294a90a93e37

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85006-1755-1850061755011 VIAL in 1 CARTON (85006-1755-1) / 16 mL in 1 VIAL1 vial2026-03-30NoNoCurrent