FDA.reportPublic FDA data

Evenity

Product NDC
55513-998
11-digit product format
555130998
Labeler code
55513
Product ID
55513-998_ce745f36-d616-4542-b53a-ad52407d1f8d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
romosozumab-aqqg
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Amgen, Inc
Application
BLA761062
Marketing category
BLA
Marketing start
2024-07-01
Substance
ROMOSOZUMAB
Active strength
105 mg/1.17mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROMOSOZUMAB105 mg/1.17mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3VHF2ZD92JInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2123184Internal RxNorm lookup
2123185Internal RxNorm lookup
2123190Internal RxNorm lookup
2123191Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
471baba2-7154-4488-9891-0db2f46791e7Available 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
9bd44bfd-2436-4701-a6e8-2952b9242f61Product name120190703
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
55513-998-01Evenity1.17 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION1.1717
55513-998-02Evenity2 in 1 CARTONINJECTION, SOLUTION217

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55513-998-01ML - Milliliter55513-99882b32dce-6599-45fb-a4af-36ec12ec3dc812024-12-10
55513-998-02ML - Milliliter55513-9984acefab6-1703-407f-a344-10b65ceac44112024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55513-998EVENITY (ROMOSOZUMAB-AQQG) INJECTION, SOLUTION [AMGEN INC]15Current NDC, 2 package rows20250419_471baba2-7154-4488-9891-0db2f46791e7.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EvenityROMOSOZUMAB-AQQGAmgen, Inc471baba2-7154-4488-9891-0db2f46791e72026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761062
ndc (product): 55513-998

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761062Evenityromosozumab-aqqg351(a)Rx2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2123191{2 (1.17 ML romosozumab-aqqg 89.7 MG/ML Prefilled Syringe [Evenity]) } Pack [Evenity 210 MG Dose]BPCK471baba2-7154-4488-9891-0db2f46791e717
2123185{2 (1.17 ML romosozumab-aqqg 89.7 MG/ML Prefilled Syringe) } PackGPCK471baba2-7154-4488-9891-0db2f46791e717
2123190Evenity 105 MG in 1.17 mL Prefilled SyringePSN471baba2-7154-4488-9891-0db2f46791e717
2123191EVENITY 210 MG Dose Pack (2 count)PSN471baba2-7154-4488-9891-0db2f46791e717
2123184romosozumab-aqqg 105 MG in 1.17 mL Prefilled SyringePSN471baba2-7154-4488-9891-0db2f46791e717
2123185romosozumab-aqqg 89.7 MG/ML in 1.17 ML Prefilled Syringe 2-Pack (210 MG Dose)PSN471baba2-7154-4488-9891-0db2f46791e717
21231901.17 ML romosozumab-aqqg 89.7 MG/ML Prefilled Syringe [Evenity]SBD471baba2-7154-4488-9891-0db2f46791e717
21231841.17 ML romosozumab-aqqg 89.7 MG/ML Prefilled SyringeSCD471baba2-7154-4488-9891-0db2f46791e717
21231901.17 ML Evenity 89.7 MG/ML Prefilled SyringeSY471baba2-7154-4488-9891-0db2f46791e717
2123190Evenity 105 MG per 1.17 ML Prefilled SyringeSY471baba2-7154-4488-9891-0db2f46791e717
2123191Evenity 210 MG Dose Pack (2 count)SY471baba2-7154-4488-9891-0db2f46791e717

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55513-998-01555130998011.17 mL in 1 SYRINGE, GLASS1.17 mlHistorical
55513-998-02555130998022 SYRINGE, GLASS in 1 CARTON (55513-998-02) / 1.17 mL in 1 SYRINGE, GLASS (55513-998-01) 2024-07-01NoNoCurrent