FDA.reportPublic FDA data

Bilprevda

Product NDC
78206-195
11-digit product format
782060195
Labeler code
78206
Product ID
78206-195_3e7e29ef-1e84-db7c-e063-6294a90a04d6
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
120 mg/1.7mL
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
Bilprevda
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DENOSUMAB120 mg/1.7mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4EQZ6YO2HI
Rxcui2723338, 2723345

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
78206-195-01Bilprevda1.7 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1.72
78206-195-01Bilprevda1 in 1 CARTONINJECTION, SOLUTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
78206-195-01ML - Milliliter78206-195edb1517c-cc45-464d-92ac-2544fe14542f12025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2723345BILPREVDA 120 MG in 1.7 ML InjectionPSNb1f0590e-f5bb-44ac-99a0-4aa4596c7e542
2723338denosumab-nxxp 120 MG in 1.7 ML InjectionPSNb1f0590e-f5bb-44ac-99a0-4aa4596c7e542
27233451.7 ML denosumab-nxxp 70 MG/ML Injection [Bilprevda]SBDb1f0590e-f5bb-44ac-99a0-4aa4596c7e542
27233381.7 ML denosumab-nxxp 70 MG/ML InjectionSCDb1f0590e-f5bb-44ac-99a0-4aa4596c7e542
2723345Bilprevda 120 MG per 1.7 ML InjectionSYb1f0590e-f5bb-44ac-99a0-4aa4596c7e542
2723338denosumab-nxxp 120 MG per 1.7 ML InjectionSYb1f0590e-f5bb-44ac-99a0-4aa4596c7e542

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
78206-195-01782060195011 VIAL, SINGLE-DOSE in 1 CARTON (78206-195-01) / 1.7 mL in 1 VIAL, SINGLE-DOSE2025-09-11NoNoCurrent