Boncresa

Product NDC
70121-2702
11-digit product format
701212702
Labeler code
70121
Product ID
70121-2702_ea835cc4-6151-4b2e-ad69-3b2c6d32b078
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
denosumab-mobz
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Amneal Pharmaceuticals LLC
Application
BLA761456
Marketing category
BLA
Marketing start
2025-12-23
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
Boncresa
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DENOSUMAB60 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4EQZ6YO2HI
Rxcui2729312, 2729319

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70121-2702-1Boncresa1 in 1 CARTONINJECTION, SOLUTION15
70121-2702-1Boncresa1 mL in 1 SYRINGEINJECTION, SOLUTION15

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2729319Boncresa 60 MG in 1 ML Prefilled SyringePSN29140df2-24a3-4a6f-a8e3-065521448d615
2729312denosumab-mobz 60 MG in 1 ML Prefilled SyringePSN29140df2-24a3-4a6f-a8e3-065521448d615
27293191 ML denosumab-mobz 60 MG/ML Prefilled Syringe [Boncresa]SBD29140df2-24a3-4a6f-a8e3-065521448d615
27293121 ML denosumab-mobz 60 MG/ML Prefilled SyringeSCD29140df2-24a3-4a6f-a8e3-065521448d615
2729319Boncresa 60 MG per 1 ML Prefilled SyringeSY29140df2-24a3-4a6f-a8e3-065521448d615
2729319Boncresa 60 MG/ML per 1 ML Prefilled SyringeSY29140df2-24a3-4a6f-a8e3-065521448d615
2729312denosumab-mobz 60 MG per 1 ML Prefilled SyringeSY29140df2-24a3-4a6f-a8e3-065521448d615
2729312denosumab-mobz 60 MG/ML per 1 ML Prefilled SyringeSY29140df2-24a3-4a6f-a8e3-065521448d615

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70121-2702-1701212702011 SYRINGE in 1 CARTON (70121-2702-1) / 1 mL in 1 SYRINGE1 syringe2025-12-23NoNoCurrent