FDA.reportPublic FDA data

Omvoh

Product NDC
0002-7717
11-digit product format
000027717
Labeler code
0002
Product ID
0002-7717_e1015232-2dfd-4b5d-b1d0-e0302e49c55a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mirikizumab-mrkz
Dosage form
KIT
Route
SUBCUTANEOUS; SUBCUTANEOUS
Labeler
Eli Lilly and Company
Application
BLA761279
Marketing category
BLA
Marketing start
2025-01-15
NDC exclude flag
No
Listing certified through
2026-12-31
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
OmvohMIRIKIZUMAB-MRKZEli Lilly and Company472cbe04-263e-433d-9a0f-58c1b50b715a2025-11-04Warnings, Adverse reactionsExact identifier
application number: BLA761279
ndc (product): 0002-7717

Additional Listing Data#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Z7HVY03PHPInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 14 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2668391Internal RxNorm lookup
2668398Internal RxNorm lookup
2668405Internal RxNorm lookup
2668410Internal RxNorm lookup
2680728Internal RxNorm lookup
2680732Internal RxNorm lookup
2703047Internal RxNorm lookup
2703048Internal RxNorm lookup
2703049Internal RxNorm lookup
2703050Internal RxNorm lookup
2703051Internal RxNorm lookup
2703052Internal RxNorm lookup
2703053Internal RxNorm lookup
2703054Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
472cbe04-263e-433d-9a0f-58c1b50b715aAvailable on FDA.report

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
0002-7717-11Omvoh1 in 1 CARTONKIT118
0002-7717-61Omvoh1 in 1 CARTONKIT118
0002-8011-01Omvoh1 mL in 1 SYRINGEINJECTION, SOLUTION1 mL100 mg in 1mL18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0002-7717-11ML - Milliliter0002-7717be35c658-44a3-441c-b8a1-24de8ac2042612025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-7717OMVOH (MIRIKIZUMAB-MRKZ) INJECTION, SOLUTION OMVOH (MIRIKIZUMAB-MRKZ) KIT [ELI LILLY AND COMPANY]14Current NDC, 4 package rows20250406_472cbe04-263e-433d-9a0f-58c1b50b715a.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761279Omvohmirikizumab-mrkz351(a)Rx2026-06-01

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
0002-7717-11000027717111 KIT in 1 CARTON (0002-7717-11) * 1 mL in 1 SYRINGE * 2 mL in 1 SYRINGE * 1 mL in 1 SYRINGE (0002-8011-01) * 2 mL in 1 SYRINGE (0002-3116-01) 1 kit2025-01-15NoNoCurrent
0002-7717-61000027717611 KIT in 1 CARTON (0002-7717-61) * 1 mL in 1 SYRINGE * 2 mL in 1 SYRINGE * 1 mL in 1 SYRINGE (0002-8011-01) * 2 mL in 1 SYRINGE (0002-3116-01) 1 kit2025-01-15YesNoCurrent
0002-8011-01000028011011 mL in 1 SYRINGE1 mlHistorical