FDA.reportPublic FDA data

JUBBONTI

Product NDC
61314-240
11-digit product format
613140240
Labeler code
61314
Product ID
61314-240_3f864a08-c693-4fdf-8158-c9e0d956fcad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
denosumab
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Sandoz Inc
Application
BLA761362
Marketing category
BLA
Marketing start
2025-06-02
Substance
DENOSUMAB
Active strength
60 mg/mL
Pharmacologic classes
RANK Ligand Blocking Activity [MoA], RANK Ligand Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
JUBBONTI
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DENOSUMAB60 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4EQZ6YO2HIInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2715513Internal RxNorm lookup
2715520Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4bf239bb-c467-4add-b7cf-ea666e4fc693Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
31f7a69c-73ae-42bf-97ee-e31040596ed6Product name120180423
b45e2e3f-1908-4144-8fa5-6f481dea7435Product name120170721
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61314-240-63JUBBONTI1 mL in 1 SYRINGEINJECTION16
61314-240-63JUBBONTI1 in 1 CARTONINJECTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61314-240-63ML - Milliliter61314-240db3fbb71-4b82-4960-9617-96df3a1e05c112025-06-13

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
WYOSTDENOSUMABSandoz Inc69e4890d-5dd9-42a5-aa41-ce50635eaed72026-02-20Warnings, Adverse reactionsExact identifier
application number: BLA761362
JUBBONTIDENOSUMABSandoz Inc4bf239bb-c467-4add-b7cf-ea666e4fc6932025-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761362
ndc (product): 61314-240

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761362Jubbontidenosumab-bbdz351(k) InterchangeableRx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2715513denosumab-bbdz 60 MG in 1 ML Prefilled SyringePSN4bf239bb-c467-4add-b7cf-ea666e4fc6936
2715520Jubbonti 60 MG in 1 ML Prefilled SyringePSN4bf239bb-c467-4add-b7cf-ea666e4fc6936
27155201 ML denosumab-bbdz 60 MG/ML Prefilled Syringe [Jubbonti]SBD4bf239bb-c467-4add-b7cf-ea666e4fc6936
27155131 ML denosumab-bbdz 60 MG/ML Prefilled SyringeSCD4bf239bb-c467-4add-b7cf-ea666e4fc6936
27155201 ML Jubbonti 60 MG/ML Prefilled SyringeSY4bf239bb-c467-4add-b7cf-ea666e4fc6936
2715513denosumab-bbdz 60 MG per 1 ML Prefilled SyringeSY4bf239bb-c467-4add-b7cf-ea666e4fc6936
2715520Jubbonti 60 MG per 1 ML Prefilled SyringeSY4bf239bb-c467-4add-b7cf-ea666e4fc6936

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61314-240-63613140240631 SYRINGE in 1 CARTON (61314-240-63) / 1 mL in 1 SYRINGE1 syringe2025-06-02NoNoCurrent