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 Identifiers#

Field, Values table
FieldValues
Unii4EQZ6YO2HI
Rxcui993452, 993456

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

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 syringe2024-03-05NoNoHistorical