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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761062Evenityromosozumab-aqqg351(a)Rx2026-06-01

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