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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DENOSUMAB120 mg/1.7mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4EQZ6YO2HI
Rxcui1046398, 1046402

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

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-USE2025-04-15NoNoHistorical