Prescription drug · NDA
Olumiant (baricitinib) NDC 0002-4182
Baricitinib 2 mg/1 · Tablet, Film coated · Oral · Eli Lilly and Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0002-4182-30 | 00002418230 | 30 TABLET, FILM COATED in 1 BOTTLE (0002-4182-30)Marketed from May 31, 2018 | |
| 0002-4182-61 | 00002418261 | 30 TABLET, FILM COATED in 1 BOTTLE (0002-4182-61)Marketed from May 31, 2018 · 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)
- Olumiant
- Generic name (nonproprietary)
- baricitinib
- Active ingredients
- Baricitinib — 2 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Eli Lilly and Company
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 207924
- Marketing start
- Listing expires
- Other FDA classes
- Janus Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 0002-4182_bd867ca4-faaf-4920-af55-ee0db99ab1bfSPL ID bd867ca4-faaf-4920-af55-ee0db99ab1bfSPL set ID 866e9f35-9035-4581-a4b1-75a621ab55cfRxCUI 2047241, 2047247, 2205472, 2205474, 2588561, 2601725UNII ISP4442I3YUPC 0300024479302, 0300024182301, 0300024732308
- Pharmacologic class
- Janus Kinase Inhibitor
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400002418230followed by a unit qualifier and the quantityPackage 00002-4182-30. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
OLUMIANT ® is a Janus kinase (JAK) inhibitor indicated for: the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF blockers. ( 1.1 ) Limitations of Use : Not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. ( 1.1 ) the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. ( 1.2 ) the treatment of adult patients with severe alopecia areata. ( 1.3 ) Limitations of Use : Not recommended for use in combination with other JAK inhi…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 207924
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.