Evenity
These highlights do not include all the information needed to use EVENITY safely and effectively. See full prescribing information for EVENITY. EVENITY (romosozumab-aqqg) injection, for subcutaneous use Initial U.S. Approval: 2019
Approved
Approval ID
471baba2-7154-4488-9891-0db2f46791e7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 30, 2020
Manufacturers
FDA
Amgen Inc
DUNS: 039976196
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
romosozumab-aqqg
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55513-998
Application NumberBLA761062
Product Classification
M
Marketing Category
C73585
G
Generic Name
romosozumab-aqqg
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateApril 14, 2025
FDA Product Classification
INGREDIENTS (7)
ROMOSOZUMABActive
Quantity: 105 mg in 1.17 mL
Code: 3VHF2ZD92J
Classification: ACTIB
ACETATE IONInactive
Quantity: 3.8 mg in 1.17 mL
Code: 569DQM74SC
Classification: IACT
CALCIUMInactive
Quantity: 0.61 mg in 1.17 mL
Code: SY7Q814VUP
Classification: IACT
POLYSORBATE 20Inactive
Quantity: 0.07 mg in 1.17 mL
Code: 7T1F30V5YH
Classification: IACT
SUCROSEInactive
Quantity: 70 mg in 1.17 mL
Code: C151H8M554
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
romosozumab-aqqg
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55513-880
Application NumberBLA761062
Product Classification
M
Marketing Category
C73585
G
Generic Name
romosozumab-aqqg
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateApril 30, 2020
FDA Product Classification
INGREDIENTS (7)
ACETATE IONInactive
Quantity: 3.8 mg in 1.17 mL
Code: 569DQM74SC
Classification: IACT
POLYSORBATE 20Inactive
Quantity: 0.07 mg in 1.17 mL
Code: 7T1F30V5YH
Classification: IACT
CALCIUMInactive
Quantity: 0.61 mg in 1.17 mL
Code: SY7Q814VUP
Classification: IACT
SUCROSEInactive
Quantity: 70 mg in 1.17 mL
Code: C151H8M554
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ROMOSOZUMABActive
Quantity: 105 mg in 1.17 mL
Code: 3VHF2ZD92J
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Drug Labeling Information
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 10/31/2024
CLINICAL PHARMACOLOGY SECTION
LOINC: 34090-1Updated: 10/31/2024
NONCLINICAL TOXICOLOGY SECTION
LOINC: 43680-8Updated: 10/31/2024
CLINICAL STUDIES SECTION
LOINC: 34092-7Updated: 10/31/2024
HOW SUPPLIED SECTION
LOINC: 34069-5Updated: 10/31/2024
SPL MEDGUIDE SECTION
LOINC: 42231-1Updated: 10/31/2024
RECENT MAJOR CHANGES SECTION
LOINC: 43683-2Updated: 10/31/2024
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 10/31/2024