FDA.reportPublic FDA data

JUBEREQ

Product NDC
69448-022
Requested package NDC
69448-022-63
11-digit product format
694480022
Labeler code
69448
Product ID
69448-022_caa201eb-143f-4390-9788-894e1810fee8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
denosumab-desu
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Accord BioPharma Inc.
Application
BLA761424
Marketing category
BLA
Marketing start
2026-07-13
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
JUBEREQ
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DENOSUMAB70 mg/mL

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
2747255Internal RxNorm lookup
2747262Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e15dfe74-1575-4a2a-895e-323c05613362Available on FDA.report

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
JUBEREQDENOSUMAB-DESUAccord BioPharma Inc.e15dfe74-1575-4a2a-895e-323c056133622026-07-14Warnings, Adverse reactionsExact identifier
application number: BLA761424
ndc (package): 69448-022-63
ndc (product): 69448-022
ndc11 (package): 69448002263
OSVYRTIDENOSUMAB-DESUAccord BioPharma Inc.5f3be096-5100-4d0e-b765-481bbb2672e12026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761424

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761424Osvyrtidenosumab-desu351(k) InterchangeableRx2026-09-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69448-022-63694480022631 VIAL, SINGLE-USE in 1 CARTON (69448-022-63) / 1.7 mL in 1 VIAL, SINGLE-USE2026-07-13NoNoCurrent