FDA.reportPublic FDA data

WYOST

Product NDC
61314-228
11-digit product format
613140228
Labeler code
61314
Product ID
61314-228_c0ae96a3-47b7-4b70-98a2-e88074ff6f10
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
120 mg/1.7mL
Pharmacologic classes
RANK Ligand Blocking Activity [MoA], RANK Ligand Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
WYOST
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DENOSUMAB120 mg/1.7mL

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
2715386Internal RxNorm lookup
2715393Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
69e4890d-5dd9-42a5-aa41-ce50635eaed7Available 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
61314-228-94WYOST1 in 1 CARTONINJECTION16
61314-228-94WYOST1.7 mL in 1 VIAL, SINGLE-DOSEINJECTION1.76

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61314-228-94ML - Milliliter61314-2280fc2b995-cd5c-4d10-9d98-c33ab807b95312025-06-13

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
ndc (product): 61314-228
JUBBONTIDENOSUMABSandoz Inc4bf239bb-c467-4add-b7cf-ea666e4fc6932025-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761362

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
2715386denosumab-bbdz 120 MG in 1.7 ML InjectionPSN69e4890d-5dd9-42a5-aa41-ce50635eaed76
2715393Wyost 120 MG in 1.7 ML InjectionPSN69e4890d-5dd9-42a5-aa41-ce50635eaed76
27153931.7 ML denosumab-bbdz 70 MG/ML Injection [Wyost]SBD69e4890d-5dd9-42a5-aa41-ce50635eaed76
27153861.7 ML denosumab-bbdz 70 MG/ML InjectionSCD69e4890d-5dd9-42a5-aa41-ce50635eaed76
27153931.7 ML Wyost 70 MG/ML InjectionSY69e4890d-5dd9-42a5-aa41-ce50635eaed76
2715386denosumab-bbdz 120 MG per 1.7 ML InjectionSY69e4890d-5dd9-42a5-aa41-ce50635eaed76
2715393Wyost 120 MG per 1.7 ML InjectionSY69e4890d-5dd9-42a5-aa41-ce50635eaed76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
61314-228-94613140228941 VIAL, SINGLE-DOSE in 1 CARTON (61314-228-94) / 1.7 mL in 1 VIAL, SINGLE-DOSE2025-06-02NoNoCurrent