FDA.reportPublic FDA data

CONEXXENCE

Product NDC
65219-668
11-digit product format
652190668
Labeler code
65219
Product ID
65219-668_f778a079-d075-4205-bc94-8ec67e27c95e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Denosumab
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Fresenius Kabi USA, LLC
Application
BLA761398
Marketing category
BLA
Marketing start
2025-06-30
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
CONEXXENCE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DENOSUMAB60 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
2717531Internal RxNorm lookup
2717538Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
39a0a789-778f-4695-b3a9-61643e6396cdAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
31f7a69c-73ae-42bf-97ee-e31040596ed6Product name120180423
b45e2e3f-1908-4144-8fa5-6f481dea7435Product name120170721
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-668-01CONEXXENCE1 in 1 CARTONINJECTION13
65219-668-01CONEXXENCE1 mL in 1 SYRINGE, PLASTICINJECTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-668-01ML - Milliliter65219-66825cb093b-38cf-4510-8440-50ed0525a14212025-08-11

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
CONEXXENCEDENOSUMABFresenius Kabi USA, LLC39a0a789-778f-4695-b3a9-61643e6396cd2025-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761398
ndc (product): 65219-668
BOMYNTRADENOSUMABFresenius Kabi USA, LLC49d25732-e05d-47e4-98cb-67df04796d4b2025-03-31Warnings, Adverse reactionsExact identifier
application number: BLA761398

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761398Conexxencedenosumab-bnht351(k) InterchangeableRx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2717538Conexxence 60 MG in 1 ML Prefilled SyringePSN39a0a789-778f-4695-b3a9-61643e6396cd3
2717531denosumab-bnht 60 MG in 1 ML Prefilled SyringePSN39a0a789-778f-4695-b3a9-61643e6396cd3
27175381 ML denosumab-bnht 60 MG/ML Prefilled Syringe [Conexxence]SBD39a0a789-778f-4695-b3a9-61643e6396cd3
27175311 ML denosumab-bnht 60 MG/ML Prefilled SyringeSCD39a0a789-778f-4695-b3a9-61643e6396cd3
2717538Conexxence 60 MG per 1 ML Prefilled SyringeSY39a0a789-778f-4695-b3a9-61643e6396cd3
2717538Conexxence 60 MG/ML per 1 ML Prefilled SyringeSY39a0a789-778f-4695-b3a9-61643e6396cd3
2717531denosumab-bnht 60 MG per 1 ML Prefilled SyringeSY39a0a789-778f-4695-b3a9-61643e6396cd3
2717531denosumab-bnht 60 MG/ML per 1 ML Prefilled SyringeSY39a0a789-778f-4695-b3a9-61643e6396cd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
65219-668-01652190668011 SYRINGE, PLASTIC in 1 CARTON (65219-668-01) / 1 mL in 1 SYRINGE, PLASTIC2025-06-30NoNoCurrent