Omvoh
These highlights do not include all the information needed to use OMVOH safely and effectively. See full prescribing information for OMVOH. OMVOH (mirikizumab-mrkz) injection, for intravenous or subcutaneous use Initial U.S. Approval: 2023
Approved
Approval ID
472cbe04-263e-433d-9a0f-58c1b50b715a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 6, 2023
Manufacturers
FDA
Eli Lilly and Company
DUNS: 006421325
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
mirikizumab-mrkz
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0002-7575
Application NumberBLA761279
Product Classification
M
Marketing Category
C73585
G
Generic Name
mirikizumab-mrkz
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 26, 2023
FDA Product Classification
INGREDIENTS (6)
mirikizumabActive
Quantity: 20 mg in 1 mL
Code: Z7HVY03PHP
Classification: ACTIB
anhydrous citric acidInactive
Quantity: 0.4 mg in 1 mL
Code: XF417D3PSL
Classification: IACT
trisodium citrate dihydrateInactive
Quantity: 2.4 mg in 1 mL
Code: B22547B95K
Classification: IACT
sodium chlorideInactive
Quantity: 8.8 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
polysorbate 80Inactive
Quantity: 0.5 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
mirikizumab-mrkz
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0002-8011
Application NumberBLA761279
Product Classification
M
Marketing Category
C73585
G
Generic Name
mirikizumab-mrkz
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateOctober 26, 2023
FDA Product Classification
INGREDIENTS (6)
trisodium citrate dihydrateInactive
Quantity: 2.4 mg in 1 mL
Code: B22547B95K
Classification: IACT
polysorbate 80Inactive
Quantity: 0.3 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
mirikizumabActive
Quantity: 100 mg in 1 mL
Code: Z7HVY03PHP
Classification: ACTIB
anhydrous citric acidInactive
Quantity: 0.4 mg in 1 mL
Code: XF417D3PSL
Classification: IACT
sodium chlorideInactive
Quantity: 8.8 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT