FDA.reportPublic FDA data

XGEVA

Product NDC
55513-730
11-digit product format
555130730
Labeler code
55513
Product ID
55513-730_a554622d-cdd7-4ab6-b581-a43fb6fbab45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
denosumab
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Amgen, Inc
Application
BLA125320
Marketing category
BLA
Marketing start
2010-11-18
Substance
DENOSUMAB
Active strength
120 mg/1.7mL
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
XGEVA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DENOSUMAB120 mg/1.7mL

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
1046398Internal RxNorm lookup
1046402Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
628f0998-1206-4001-aeee-18133aa9f3bfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
55513-730-01XGEVA1.7 mL in 1 VIAL, SINGLE-USEINJECTION1.7176
55513-730-01XGEVA1 in 1 CARTONINJECTION1176
55513-730-21XGEVA1 in 1 CARTONINJECTION1176
55513-730-21XGEVA1.7 mL in 1 VIAL, SINGLE-USEINJECTION1.7176

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55513-730-01ML - Milliliter55513-7302568a786-cbdf-4572-aa5b-4ebddeeb295212012-07-24
55513-730-21ML - Milliliter55513-7306b17d572-b544-4ea6-a225-18177602667412025-12-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DENOSUMABACTIVE INGREDIENT4EQZ6YO2HIXGEVA (DENOSUMAB) INJECTION [AMGEN INC]147
DENOSUMABACTIVE MOIETY4EQZ6YO2HIXGEVA (DENOSUMAB) INJECTION [AMGEN INC]147
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BXGEVA (DENOSUMAB) INJECTION [AMGEN INC]147
SORBITOLINACTIVE INGREDIENT506T60A25RXGEVA (DENOSUMAB) INJECTION [AMGEN INC]147
WATERINACTIVE INGREDIENT059QF0KO0RXGEVA (DENOSUMAB) INJECTION [AMGEN INC]147

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55513-730XGEVA (DENOSUMAB) INJECTION [AMGEN, INC]174Current NDC, Legacy NDC, 4 package rows20250515_628f0998-1206-4001-aeee-18133aa9f3bf.zip

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
ProliaDENOSUMABAmgen, Inc49e5afe9-a0c7-40c4-af9f-f287a80c5c882026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125320
XGEVADENOSUMABAmgen, Inc628f0998-1206-4001-aeee-18133aa9f3bf2026-06-23Warnings, Adverse reactionsExact identifier
application number: BLA125320
ndc (product): 55513-730

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125320Proliadenosumab351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046398denosumab 120 MG in 1.7 ML InjectionPSN628f0998-1206-4001-aeee-18133aa9f3bf176
1046402Xgeva 120 MG in 1.7 ML InjectionPSN628f0998-1206-4001-aeee-18133aa9f3bf176
10464021.7 ML denosumab 70 MG/ML Injection [Xgeva]SBD628f0998-1206-4001-aeee-18133aa9f3bf176
10463981.7 ML denosumab 70 MG/ML InjectionSCD628f0998-1206-4001-aeee-18133aa9f3bf176
1046398denosumab 120 MG per 1.7 ML InjectionSY628f0998-1206-4001-aeee-18133aa9f3bf176
1046402Xgeva 120 MG per 1.7 ML InjectionSY628f0998-1206-4001-aeee-18133aa9f3bf176

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55513-730-01555130730011 VIAL, SINGLE-USE in 1 CARTON (55513-730-01) / 1.7 mL in 1 VIAL, SINGLE-USE2010-11-180000-00-00NoNoCurrent
55513-730-21555130730211 VIAL, SINGLE-USE in 1 CARTON (55513-730-21) / 1.7 mL in 1 VIAL, SINGLE-USE2025-04-15NoNoCurrent