FDA.reportPublic FDA data

Oziltus

Product NDC
70121-2701
11-digit product format
701212701
Labeler code
70121
Product ID
70121-2701_165cbe29-f9fd-492f-a604-0979ed765680
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
denosumab-mobz
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Amneal Pharmaceuticals LLC
Application
BLA761457
Marketing category
BLA
Marketing start
2025-12-23
Substance
DENOSUMAB
Active strength
70 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
Oziltus
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DENOSUMAB70 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
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70121-2701-1Oziltus1.7 mL in 1 VIALINJECTION, SOLUTION1.74
70121-2701-1Oziltus1 in 1 CARTONINJECTION, SOLUTION14

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
OziltusDENOSUMAB-MOBZAmneal Pharmaceuticals LLCf040a245-1be4-4962-a8b7-a13ee7fac7072025-12-22Warnings, Adverse reactionsExact identifier
application number: BLA761457
ndc (product): 70121-2701

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761457Oziltusdenosumab-mobz351(k) InterchangeableRx2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2729323denosumab-mobz 120 MG in 1.7 ML InjectionPSNf040a245-1be4-4962-a8b7-a13ee7fac7074
2729330Oziltus 120 MG in 1.7 ML InjectionPSNf040a245-1be4-4962-a8b7-a13ee7fac7074
27293301.7 ML denosumab-mobz 70 MG/ML Injection [Oziltus]SBDf040a245-1be4-4962-a8b7-a13ee7fac7074
27293231.7 ML denosumab-mobz 70 MG/ML InjectionSCDf040a245-1be4-4962-a8b7-a13ee7fac7074
2729323denosumab-mobz 120 MG per 1.7 ML InjectionSYf040a245-1be4-4962-a8b7-a13ee7fac7074
2729323denosumab-mobz 70 MG/ML per 1.7 ML InjectionSYf040a245-1be4-4962-a8b7-a13ee7fac7074
2729330Oziltus 120 MG per 1.7 ML InjectionSYf040a245-1be4-4962-a8b7-a13ee7fac7074
2729330Oziltus 70 MG/ML per 1.7 ML InjectionSYf040a245-1be4-4962-a8b7-a13ee7fac7074

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70121-2701-1701212701011 VIAL in 1 CARTON (70121-2701-1) / 1.7 mL in 1 VIAL1 vial2025-12-23NoNoCurrent