FDA.reportPublic FDA data

Omvoh

Product NDC
0002-3116
11-digit product format
000023116
Labeler code
0002
Product ID
0002-3116_e1015232-2dfd-4b5d-b1d0-e0302e49c55a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mirikizumab-mrkz
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Eli Lilly and Company
Application
BLA761279
Marketing category
BLA
Marketing start
2025-10-23
Substance
MIRIKIZUMAB
Active strength
100 mg/mL
Pharmacologic classes
Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Omvoh
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MIRIKIZUMAB100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZ7HVY03PHP
Rxcui2668391, 2668398, 2668405, 2668410, 2680728, 2680732, 2703047, 2703048, 2703049, 2703050, 2703051, 2703052, 2703053, 2703054

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63103eb4-adaa-4a90-8c72-69f4cc5a37ebProduct name120250214
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0002-3116-01Omvoh2 mL in 1 SYRINGEINJECTION, SOLUTION2 mL100 mg in 1mL18
0002-3116-01Omvoh2 mL in 1 SYRINGEINJECTION, SOLUTION218
0002-3116-11Omvoh1 in 1 CARTONINJECTION, SOLUTION118
0002-3116-61Omvoh1 in 1 CARTONINJECTION, SOLUTION118
0002-3116-61Omvoh2 mL in 1 SYRINGEINJECTION, SOLUTION218

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0002-3116-01ML - Milliliter0002-3116e059bd64-d38a-4ce5-b4f7-a67eb476839b12025-12-16
0002-3116-11ML - Milliliter0002-3116bd473794-5bfd-4601-9e5a-d1ba8eee464f12026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-3116OMVOH (MIRIKIZUMAB-MRKZ) INJECTION, SOLUTION OMVOH (MIRIKIZUMAB-MRKZ) KIT [ELI LILLY AND COMPANY]14Current NDC, 4 package rows20250406_472cbe04-263e-433d-9a0f-58c1b50b715a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2703052{1 (1 ML mirikizumab-mrkz 100 MG/ML Auto-Injector [Omvoh]) / 1 (2 ML mirikizumab-mrkz 100 MG/ML Auto-Injector [Omvoh]) } Pack [Omvoh Prefilled Pen 300 MG Dose Carton]BPCK472cbe04-263e-433d-9a0f-58c1b50b715a18
2703054{1 (1 ML mirikizumab-mrkz 100 MG/ML Prefilled Syringe [Omvoh]) / 1 (2 ML mirikizumab-mrkz 100 MG/ML Prefilled Syringe [Omvoh]) } Pack [Omvoh Prefilled Syringe 300 MG Dose Carton]BPCK472cbe04-263e-433d-9a0f-58c1b50b715a18
2703051{1 (1 ML mirikizumab-mrkz 100 MG/ML Auto-Injector) / 1 (2 ML mirikizumab-mrkz 100 MG/ML Auto-Injector) } PackGPCK472cbe04-263e-433d-9a0f-58c1b50b715a18
2703053{1 (1 ML mirikizumab-mrkz 100 MG/ML Prefilled Syringe) / 1 (2 ML mirikizumab-mrkz 100 MG/ML Prefilled Syringe) } PackGPCK472cbe04-263e-433d-9a0f-58c1b50b715a18
2668405mirikizumab-mrkz 100 MG in 1 ML Auto-InjectorPSN472cbe04-263e-433d-9a0f-58c1b50b715a18
2680728mirikizumab-mrkz 100 MG in 1 ML Prefilled SyringePSN472cbe04-263e-433d-9a0f-58c1b50b715a18
2703049mirikizumab-mrkz 200 MG in 2 ML Auto-InjectorPSN472cbe04-263e-433d-9a0f-58c1b50b715a18
2703047mirikizumab-mrkz 200 MG in 2 ML Prefilled SyringePSN472cbe04-263e-433d-9a0f-58c1b50b715a18
2668391mirikizumab-mrkz 300 MG in 15 ML InjectionPSN472cbe04-263e-433d-9a0f-58c1b50b715a18
2703051mirikizumab-mrkz Prefilled Pen 300 MG Dose Carton - Crohn's DiseasePSN472cbe04-263e-433d-9a0f-58c1b50b715a18
2703053mirikizumab-mrkz Prefilled Syringe 300 MG Dose Carton - Crohn's DiseasePSN472cbe04-263e-433d-9a0f-58c1b50b715a18
2668410omvoh 100 MG in 1 ML Auto-InjectorPSN472cbe04-263e-433d-9a0f-58c1b50b715a18
2680732omvoh 100 MG in 1 ML Prefilled SyringePSN472cbe04-263e-433d-9a0f-58c1b50b715a18
2703050omvoh 200 MG in 2 ML Auto-InjectorPSN472cbe04-263e-433d-9a0f-58c1b50b715a18
2703048omvoh 200 MG in 2 ML Prefilled SyringePSN472cbe04-263e-433d-9a0f-58c1b50b715a18
2668398omvoh 300 MG in 15 ML InjectionPSN472cbe04-263e-433d-9a0f-58c1b50b715a18
2703052omvoh Prefilled Pen 300 MG Dose Carton - Crohn's DiseasePSN472cbe04-263e-433d-9a0f-58c1b50b715a18
2703054omvoh Prefilled Syringe 300 MG Dose Carton - Crohn's DiseasePSN472cbe04-263e-433d-9a0f-58c1b50b715a18
26684101 ML mirikizumab-mrkz 100 MG/ML Auto-Injector [Omvoh]SBD472cbe04-263e-433d-9a0f-58c1b50b715a18
26807321 ML mirikizumab-mrkz 100 MG/ML Prefilled Syringe [Omvoh]SBD472cbe04-263e-433d-9a0f-58c1b50b715a18
266839815 ML mirikizumab-mrkz 20 MG/ML Injection [Omvoh]SBD472cbe04-263e-433d-9a0f-58c1b50b715a18
27030502 ML mirikizumab-mrkz 100 MG/ML Auto-Injector [Omvoh]SBD472cbe04-263e-433d-9a0f-58c1b50b715a18
27030482 ML mirikizumab-mrkz 100 MG/ML Prefilled Syringe [Omvoh]SBD472cbe04-263e-433d-9a0f-58c1b50b715a18
26684051 ML mirikizumab-mrkz 100 MG/ML Auto-InjectorSCD472cbe04-263e-433d-9a0f-58c1b50b715a18
26807281 ML mirikizumab-mrkz 100 MG/ML Prefilled SyringeSCD472cbe04-263e-433d-9a0f-58c1b50b715a18
266839115 ML mirikizumab-mrkz 20 MG/ML InjectionSCD472cbe04-263e-433d-9a0f-58c1b50b715a18
27030492 ML mirikizumab-mrkz 100 MG/ML Auto-InjectorSCD472cbe04-263e-433d-9a0f-58c1b50b715a18
27030472 ML mirikizumab-mrkz 100 MG/ML Prefilled SyringeSCD472cbe04-263e-433d-9a0f-58c1b50b715a18
26684101 ML Omvoh 100 MG/ML Auto-InjectorSY472cbe04-263e-433d-9a0f-58c1b50b715a18
266839815 ML Omvoh 20 MG/ML InjectionSY472cbe04-263e-433d-9a0f-58c1b50b715a18
27030502 ML Omvoh 100 MG/ML Auto-InjectorSY472cbe04-263e-433d-9a0f-58c1b50b715a18
27030482 ML Omvoh 100 MG/ML Prefilled SyringeSY472cbe04-263e-433d-9a0f-58c1b50b715a18
2668405mirikizumab-mrkz 100 MG per 1 ML Auto-InjectorSY472cbe04-263e-433d-9a0f-58c1b50b715a18
2680728mirikizumab-mrkz 100 MG per 1 ML Prefilled SyringeSY472cbe04-263e-433d-9a0f-58c1b50b715a18
2703049mirikizumab-mrkz 200 MG per 2 ML Auto-InjectorSY472cbe04-263e-433d-9a0f-58c1b50b715a18
2703047mirikizumab-mrkz 200 MG per 2 ML Prefilled SyringeSY472cbe04-263e-433d-9a0f-58c1b50b715a18
2668391mirikizumab-mrkz 300 MG per 15 ML InjectionSY472cbe04-263e-433d-9a0f-58c1b50b715a18
2703051mirikizumab-mrkz Prefilled Pen 300 MG Dose Carton - Crohn's DiseaseSY472cbe04-263e-433d-9a0f-58c1b50b715a18
2703053mirikizumab-mrkz Prefilled Syringe 300 MG Dose Carton - Crohn's DiseaseSY472cbe04-263e-433d-9a0f-58c1b50b715a18
2668410Omvoh 100 MG per 1 ML Auto-InjectorSY472cbe04-263e-433d-9a0f-58c1b50b715a18
2680732Omvoh 100 MG per 1 ML Prefilled SyringeSY472cbe04-263e-433d-9a0f-58c1b50b715a18
2703050Omvoh 200 MG per 2 ML Auto-InjectorSY472cbe04-263e-433d-9a0f-58c1b50b715a18
2703048Omvoh 200 MG per 2 ML Prefilled SyringeSY472cbe04-263e-433d-9a0f-58c1b50b715a18
2668398Omvoh 300 MG per 15 ML InjectionSY472cbe04-263e-433d-9a0f-58c1b50b715a18
2703052Omvoh Prefilled Pen 300 MG Dose Carton - Crohn's DiseaseSY472cbe04-263e-433d-9a0f-58c1b50b715a18
2703054Omvoh Prefilled Syringe 300 MG Dose Carton - Crohn's DiseaseSY472cbe04-263e-433d-9a0f-58c1b50b715a18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0002-3116-01000023116012 mL in 1 SYRINGE2 mlHistorical
0002-3116-11000023116111 SYRINGE in 1 CARTON (0002-3116-11) / 2 mL in 1 SYRINGE (0002-3116-01) 1 syringe2025-10-23NoNoHistorical
0002-3116-61000023116611 SYRINGE in 1 CARTON (0002-3116-61) / 2 mL in 1 SYRINGE1 syringe2025-11-06YesNoHistorical