Prescription drug · BLA
Omvoh (mirikizumab-mrkz) NDC 0002-8011
Mirikizumab 100 mg/mL · Injection, Solution · Subcutaneous · Eli Lilly and Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0002-8011-27 | 00002801127 | 2 SYRINGE in 1 CARTON (0002-8011-27) / 1 mL in 1 SYRINGE (0002-8011-01)Marketed from Oct 26, 2023 | |
| 0002-8011-61 | 00002801161 | 2 SYRINGE in 1 CARTON (0002-8011-61) / 1 mL in 1 SYRINGEMarketed from Jan 16, 2024 · Sample package |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Omvoh
- Generic name (nonproprietary)
- mirikizumab-mrkz
- Active ingredients
- Mirikizumab — 100 mg/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Eli Lilly and Company
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761279
- Marketing start
- Listing expires
- Other FDA classes
- Interleukin-23 Antagonists (Mechanism)
- Identifiers
- Product ID 0002-8011_3553ca93-cbe0-4286-b806-a423598eb42aSPL ID 3553ca93-cbe0-4286-b806-a423598eb42aSPL set ID 472cbe04-263e-433d-9a0f-58c1b50b715aRxCUI 2668391, 2668398, 2668405, 2668410, 2680728, 2680732, 2703047, 2703048, 2703049, 2703050, 2703051, 2703052, 2703053, 2703054UNII Z7HVY03PHP
- Pharmacologic class
- Interleukin-23 Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400002801127followed by a unit qualifier and the quantityPackage 00002-8011-27. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
OMVOH is indicated for the treatment of: moderately to severely active ulcerative colitis in adults. moderately to severely active Crohn's disease in adults. OMVOH TM is an interleukin-23 antagonist indicated for the treatment of: moderately to severely active ulcerative colitis in adults ( 1 ) moderately to severely active Crohn's disease in adults ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 761279
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Omvohmirikizumab-mrkz | — | KitSubcutaneous, Subcutaneous | Eli Lilly and Company | 0002-7717 |
| Omvohmirikizumab-mrkz | Mirikizumab 20 mg/mL | Injection, SolutionIntravenous | Eli Lilly and Company | 0002-7575 |
| Omvohmirikizumab-mrkz | Mirikizumab 100 mg/mL | Injection, SolutionSubcutaneous | Eli Lilly and Company | 0002-8870 |
| Omvohmirikizumab-mrkz | — | KitSubcutaneous, Subcutaneous | Eli Lilly and Company | 0002-7722 |
| Omvohmirikizumab-mrkz | Mirikizumab 100 mg/mL | Injection, SolutionSubcutaneous | Eli Lilly and Company | 0002-1442 |
| Omvohmirikizumab-mrkz | Mirikizumab 100 mg/mL | Injection, SolutionSubcutaneous | Eli Lilly and Company | 0002-3116 |