FDA.reportPublic FDA data

Boncresa

Product NDC
70121-2702
11-digit product format
701212702
Labeler code
70121
Product ID
70121-2702_ce1cc8e9-0200-4ef2-beef-d21abdc3d31d
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
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DENOSUMAB60 mg/mL

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

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
BoncresaDENOSUMAB-MOBZAmneal Pharmaceuticals LLC29140df2-24a3-4a6f-a8e3-065521448d612025-12-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761456
ndc (product): 70121-2702

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761456Boncresadenosumab-mobz351(k) InterchangeableRx2026-09-01

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