FDA.reportPublic FDA data

BILDYOS

Product NDC
78206-193
11-digit product format
782060193
Labeler code
78206
Product ID
78206-193_3e7e35c0-50a6-0266-e063-6394a90a3736
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Denosumab
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Organon LLC
Application
BLA761444
Marketing category
BLA
Marketing start
2025-09-11
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
BILDYOS
Listing expiration
2027-12-31

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
2723350Internal RxNorm lookup
2723357Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b9e32bf7-d70a-4083-8577-c15751c7f769Available 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
78206-193-01BILDYOS1 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION12
78206-193-01BILDYOS1 in 1 CARTONINJECTION, SOLUTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
78206-193-01ML - Milliliter78206-193041e8a0a-4c71-49d0-8136-df284c8f077612025-10-14

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
BILDYOSDENOSUMABOrganon LLCb9e32bf7-d70a-4083-8577-c15751c7f7692026-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761444
ndc (product): 78206-193
BilprevdaDENOSUMABOrganon LLCb1f0590e-f5bb-44ac-99a0-4aa4596c7e542026-08-18Warnings, Adverse reactionsExact identifier
application number: BLA761444

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761444Bildyosdenosumab-nxxp351(k) InterchangeableRx2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2723357BILDYOS 60 MG in 1 ML Prefilled SyringePSNb9e32bf7-d70a-4083-8577-c15751c7f7692
2723350denosumab-nxxp 60 MG in 1 ML Prefilled SyringePSNb9e32bf7-d70a-4083-8577-c15751c7f7692
27233571 ML denosumab-nxxp 60 MG/ML Prefilled Syringe [Bildyos]SBDb9e32bf7-d70a-4083-8577-c15751c7f7692
27233501 ML denosumab-nxxp 60 MG/ML Prefilled SyringeSCDb9e32bf7-d70a-4083-8577-c15751c7f7692
2723357Bildyos 60 MG per 1 ML Prefilled SyringeSYb9e32bf7-d70a-4083-8577-c15751c7f7692
2723350denosumab-nxxp 60 MG per 1 ML Prefilled SyringeSYb9e32bf7-d70a-4083-8577-c15751c7f7692

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
78206-193-01782060193011 SYRINGE, GLASS in 1 CARTON (78206-193-01) / 1 mL in 1 SYRINGE, GLASS2025-09-11NoNoCurrent