Prescription drug · NDA
Ninlaro (ixazomib) NDC 63020-230
Ixazomib citrate 2.3 mg/1 · Capsule · Oral · Takeda Pharmaceuticals America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63020-230-01 | 63020023001 | 1 CAPSULE in 1 BLISTER PACK (63020-230-01)Marketed from Nov 20, 2015 | |
| 63020-230-02 | 63020023002 | 1 BLISTER PACK in 1 CARTON (63020-230-02) / 3 CAPSULE in 1 BLISTER PACK (63020-230-03)Marketed from Nov 20, 2015 |
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)
- Ninlaro
- Generic name (nonproprietary)
- ixazomib
- Active ingredients
- Ixazomib citrate — 2.3 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208462
- Marketing start
- Listing expires
- Other FDA classes
- Proteasome Inhibitors (Mechanism)
- Identifiers
- Product ID 63020-230_184bc16b-40f1-4fd3-a70b-17bbb44eac21SPL ID 184bc16b-40f1-4fd3-a70b-17bbb44eac21SPL set ID 038f2461-834b-4488-9ebd-863c83eef5a7RxCUI 1723757, 1723763, 1723765, 1723767, 1723770, 1723772UNII 46CWK97Z3K
- Pharmacologic class
- Proteasome 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
N463020023001followed by a unit qualifier and the quantityPackage 63020-0230-01. 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)
NINLARO ® is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. NINLARO is a proteasome inhibitor indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. ( 1 ) Limitations of Use : NINLARO is not recommended for use in the maintenance setting or in newly diagnosed multiple myeloma in combination with lenalidomide and dexamethasone outside of controlled clinical trials. ( 1 ) Limitations of Use : NINLARO is not recommended for use in the maintenance setting or in newly diagnosed multip…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 208462
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.