Prescription drug · NDA
Ojjaara (Momelotinib) NDC 81864-103
Momelotinib dihydrochloride monohydrate 100 mg/1 · Tablet · Oral · GlaxoSmithKline LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81864-103-30 | 81864010330 | 30 TABLET in 1 BOTTLE (81864-103-30)Marketed from Sep 15, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Ojjaara
- Generic name (nonproprietary)
- momelotinib
- Active ingredients
- Momelotinib dihydrochloride monohydrate — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- GlaxoSmithKline LLCNDC labeler code 81864
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 216873
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 81864-103_3921e23f-5c82-4e00-9611-f017ff57c06eSPL ID 3921e23f-5c82-4e00-9611-f017ff57c06eSPL set ID 4a672fd1-eb7b-4aa9-9b23-845e4b5dc400RxCUI 2665210, 2665216, 2665218, 2665220, 2665222, 2665224UNII LDX8893L5DUPC 0381864103305, 0381864102308, 0381864101301
- Pharmacologic class
- 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
N481864010330followed by a unit qualifier and the quantityPackage 81864-0103-30. 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 .
Indications (excerpt from the label)
OJJAARA is indicated for the treatment of intermediate or high‑risk myelofibrosis (MF), including primary MF or secondary MF [post‑polycythemia vera (PV) and post‑essential thrombocythemia (ET)], in adults with anemia. OJJAARA is a kinase inhibitor indicated for the treatment of intermediate or high‑risk myelofibrosis (MF), including primary MF or secondary MF [post‑polycythemia vera (PV) and post‑essential thrombocythemia (ET)], in adults with anemia. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 81864-103
- What is NDC 81864-103?
- 81864-103 is the product NDC for Ojjaara (momelotinib), Momelotinib dihydrochloride monohydrate 100 mg/1 tablet, listed with the FDA by GlaxoSmithKline LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ojjaara (Momelotinib).
- What is the active ingredient?
- Momelotinib dihydrochloride monohydrate.
- Who is the labeler?
- GlaxoSmithKline LLC, NDC labeler code 81864. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ojjaara?
- 2 other product NDCs are listed under this name. See all Ojjaara NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ojjaara products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ojjaaramomelotinib | Momelotinib dihydrochloride monohydrate 200 mg/1 | TabletOral | GlaxoSmithKline LLC | 81864-101 | 81864-0101-30 |
| Ojjaaramomelotinib | Momelotinib dihydrochloride monohydrate 150 mg/1 | TabletOral | GlaxoSmithKline LLC | 81864-102 | 81864-0102-30 |
Other NDCs under NDA 216873
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 |
|---|---|---|---|---|
| Ojjaaramomelotinib | Momelotinib dihydrochloride monohydrate 200 mg/1 | TabletOral | GlaxoSmithKline LLC | 81864-101 |
| Ojjaaramomelotinib | Momelotinib dihydrochloride monohydrate 150 mg/1 | TabletOral | GlaxoSmithKline LLC | 81864-102 |