FDA.reportPublic FDA data

OSPOMYV

Product NDC
83457-012
11-digit product format
834570012
Labeler code
83457
Product ID
83457-012_701ab9b4-0ad7-4b34-b66f-f75b41d0e1e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
denosumab
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Cordavis Limited
Application
BLA761392
Marketing category
BLA
Marketing start
2025-10-10
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
OSPOMYV
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
2725502Internal RxNorm lookup
2725509Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e1d80a82-de52-4a34-9df3-609e50667ffbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
31f7a69c-73ae-42bf-97ee-e31040596ed6Product name120180423
b45e2e3f-1908-4144-8fa5-6f481dea7435Product name120170721
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83457-012-10OSPOMYV1 mL in 1 SYRINGEINJECTION, SOLUTION16
83457-012-10OSPOMYV1 in 1 CARTONINJECTION, SOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83457-012-10ML - Milliliter83457-012f2d55a6a-7137-494a-af9e-4e463aa5e78912025-11-13

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OSPOMYVDENOSUMABCordavis Limitede1d80a82-de52-4a34-9df3-609e50667ffb2025-11-11Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761392
ndc (product): 83457-012

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761392Ospomyvdenosumab-dssb351(k) InterchangeableRx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2725502denosumab-dssb 60 MG in 1 ML Prefilled SyringePSNe1d80a82-de52-4a34-9df3-609e50667ffb6
2725509OSPOMYV 60 MG in 1 ML Prefilled SyringePSNe1d80a82-de52-4a34-9df3-609e50667ffb6
27255091 ML denosumab-dssb 60 MG/ML Prefilled Syringe [Ospomyv]SBDe1d80a82-de52-4a34-9df3-609e50667ffb6
27255021 ML denosumab-dssb 60 MG/ML Prefilled SyringeSCDe1d80a82-de52-4a34-9df3-609e50667ffb6
27255091 ML Ospomyv 60 MG/ML Prefilled SyringeSYe1d80a82-de52-4a34-9df3-609e50667ffb6
2725502denosumab-dssb 60 MG per 1 ML Prefilled SyringeSYe1d80a82-de52-4a34-9df3-609e50667ffb6
2725509Ospomyv 60 MG per 1 ML Prefilled SyringeSYe1d80a82-de52-4a34-9df3-609e50667ffb6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83457-012-10834570012101 SYRINGE in 1 CARTON (83457-012-10) / 1 mL in 1 SYRINGE1 syringe2025-10-10NoNoCurrent