Prescription drug · NDA
Iclusig (Ponatinib hydrochloride) NDC 63020-536
Ponatinib hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Takeda Pharmaceuticals America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63020-536-30 | 6302005363063020053630 | 30 TABLET, FILM COATED in 1 BOTTLE (63020-536-30)Marketed from Jan 11, 2021 |
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)
- Iclusig
- Generic name (nonproprietary)
- ponatinib hydrochloride
- Active ingredients
- Ponatinib hydrochloride — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Takeda Pharmaceuticals America, Inc.NDC labeler code 63020
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 203469
- Marketing start
- Listing expires
- Other FDA classes
- Protein Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 63020-536_2034440d-14ab-475e-affc-5261ac3683a6SPL ID 2034440d-14ab-475e-affc-5261ac3683a6SPL set ID 16d804b6-4957-43ee-b18c-3b36ec37c5acRxCUI 1364352, 1364358, 1364360, 1364362, 1726637, 1726639, 2473040, 2473042UNII 96R6PU3D8J
- 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
N463020053630followed by a unit qualifier and the quantityPackage 63020-0536-30. 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)
ICLUSIG ® is indicated for the treatment of adult patients with: Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) Newly diagnosed Ph+ ALL in combination with chemotherapy. This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete remission (CR) at the end of induction [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). As monotherapy in Ph+ ALL for whom no other kinase inhibitors are indicated or T315I-positive Ph+ ALL. Chronic Myeloid Leukemia (CML) Chronic phase (CP) CML with resistance or intolerance to at least…
Excerpt only. Read the full label for complete information.
About NDC 63020-536
- What is NDC 63020-536?
- 63020-536 is the product NDC for Iclusig (ponatinib hydrochloride), Ponatinib hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Takeda Pharmaceuticals America, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Iclusig (Ponatinib hydrochloride).
- What is the active ingredient?
- Ponatinib hydrochloride.
- Who is the labeler?
- Takeda Pharmaceuticals America, Inc., NDC labeler code 63020. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Iclusig?
- 3 other product NDCs are listed under this name. See all Iclusig NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Iclusig products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Iclusigponatinib hydrochloride | Ponatinib hydrochloride 30 mg/1 | Tablet, Film coatedOral | Takeda Pharmaceuticals America, Inc. | 63020-533 | 63020-0533-30 |
| Iclusigponatinib hydrochloride | Ponatinib hydrochloride 45 mg/1 | Tablet, Film coatedOral | Takeda Pharmaceuticals America, Inc. | 63020-534 | 63020-0534-30 |
| Iclusigponatinib hydrochloride | Ponatinib hydrochloride 15 mg/1 | Tablet, Film coatedOral | Takeda Pharmaceuticals America, Inc. | 63020-535 | 63020-0535-3063020-0535-60 |
Other NDCs under NDA 203469
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 |
|---|---|---|---|---|
| Iclusigponatinib hydrochloride | Ponatinib hydrochloride 30 mg/1 | Tablet, Film coatedOral | Takeda Pharmaceuticals America, Inc. | 63020-533 |
| Iclusigponatinib hydrochloride | Ponatinib hydrochloride 45 mg/1 | Tablet, Film coatedOral | Takeda Pharmaceuticals America, Inc. | 63020-534 |
| Iclusigponatinib hydrochloride | Ponatinib hydrochloride 15 mg/1 | Tablet, Film coatedOral | Takeda Pharmaceuticals America, Inc. | 63020-535 |