FDA.reportPublic FDA data

Prolia

Product NDC
55513-710
11-digit product format
555130710
Labeler code
55513
Product ID
55513-710_ccac6498-945e-4b9c-93b3-b3687c1f1ccb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
denosumab
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Amgen, Inc
Application
BLA125320
Marketing category
BLA
Marketing start
2010-06-05
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Prolia
Listing expiration
2027-12-31

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
993452Internal RxNorm lookup
993456Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
49e5afe9-a0c7-40c4-af9f-f287a80c5c88Available 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
55513-710-01Prolia1 in 1 CARTONINJECTION1185
55513-710-01Prolia1 mL in 1 SYRINGEINJECTION1185
55513-710-21Prolia1 mL in 1 SYRINGEINJECTION1185
55513-710-21Prolia1 in 1 CARTONINJECTION1185

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55513-710-01ML - Milliliter55513-7102688daa4-5912-4be3-994c-4e6008f68c3912012-07-24
55513-710-21ML - Milliliter55513-710cdc73bf7-ec53-4be5-8243-66ce4558ff8112024-10-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DENOSUMABACTIVE INGREDIENT4EQZ6YO2HIPROLIA (DENOSUMAB) INJECTION [AMGEN INC]147
DENOSUMABACTIVE MOIETY4EQZ6YO2HIPROLIA (DENOSUMAB) INJECTION [AMGEN INC]147
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHPROLIA (DENOSUMAB) INJECTION [AMGEN INC]147
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BPROLIA (DENOSUMAB) INJECTION [AMGEN INC]147
SORBITOLINACTIVE INGREDIENT506T60A25RPROLIA (DENOSUMAB) INJECTION [AMGEN INC]147
WATERINACTIVE INGREDIENT059QF0KO0RPROLIA (DENOSUMAB) INJECTION [AMGEN INC]147

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55513-710PROLIA (DENOSUMAB) INJECTION [AMGEN, INC]180Current NDC, Legacy NDC, 4 package rows20250510_49e5afe9-a0c7-40c4-af9f-f287a80c5c88.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
ndc (product): 55513-710
XGEVADENOSUMABAmgen, Inc628f0998-1206-4001-aeee-18133aa9f3bf2026-06-23Warnings, Adverse reactionsExact identifier
application number: BLA125320

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
993452denosumab 60 MG in 1 ML Prefilled SyringePSN49e5afe9-a0c7-40c4-af9f-f287a80c5c88185
993456Prolia 60 MG in 1 ML Prefilled SyringePSN49e5afe9-a0c7-40c4-af9f-f287a80c5c88185
9934561 ML denosumab 60 MG/ML Prefilled Syringe [Prolia]SBD49e5afe9-a0c7-40c4-af9f-f287a80c5c88185
9934521 ML denosumab 60 MG/ML Prefilled SyringeSCD49e5afe9-a0c7-40c4-af9f-f287a80c5c88185
9934561 ML Prolia 60 MG/ML Prefilled SyringeSY49e5afe9-a0c7-40c4-af9f-f287a80c5c88185
993452denosumab 60 MG per 1 ML Prefilled SyringeSY49e5afe9-a0c7-40c4-af9f-f287a80c5c88185
993456Prolia 60 MG per 1 ML Prefilled SyringeSY49e5afe9-a0c7-40c4-af9f-f287a80c5c88185

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55513-710-01555130710011 SYRINGE in 1 CARTON (55513-710-01) / 1 mL in 1 SYRINGE1 syringe2010-06-050000-00-00NoNoCurrent
55513-710-21555130710211 SYRINGE in 1 CARTON (55513-710-21) / 1 mL in 1 SYRINGE1 syringe2024-03-05NoNoCurrent