Prescription drug · NDA
Ibrance (palbociclib) NDC 63539-284
Palbociclib 75 mg/1 · Tablet, Film coated · Oral · U.S. Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63539-284-03 | 63539028403 | 3 DOSE PACK in 1 CARTON (63539-284-03) / 7 TABLET, FILM COATED in 1 DOSE PACK (63539-284-07)Marketed from Mar 30, 2020 · Sample package |
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)
- Ibrance
- Generic name (nonproprietary)
- palbociclib
- Active ingredients
- Palbociclib — 75 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- U.S. Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 212436
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 3A Inhibitors (Mechanism)Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 63539-284_342c459f-fe40-4422-bc31-88d16fbbd4dfSPL ID 342c459f-fe40-4422-bc31-88d16fbbd4dfSPL set ID 89a142d5-7e61-48bf-9e77-e2cd124c4792RxCUI 2284102, 2284104, 2284105, 2284106, 2284107, 2284108UNII G9ZF61LE7G
- 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
N463539028403followed by a unit qualifier and the quantityPackage 63539-0284-03. 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)
IBRANCE is a kinase inhibitor indicated: • for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with: o an aromatase inhibitor as initial endocrine-based therapy ( 1.1 ); or o fulvestrant in patients with disease progression following endocrine therapy. ( 1.1 ) • in combination with inavolisib and fulvestrant for the treatment of adult patients with endocrine-resistant, PIK3CA -mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, as detected by an FDA‑authorized test, following recurrence on or after completing adjuvant endocrine thera…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 212436
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 |
|---|---|---|---|---|
| Ibrancepalbociclib | Palbociclib 125 mg/1 | Tablet, Film coatedOral | U.S. Pharmaceuticals | 63539-688 |
| Ibrancepalbociclib | Palbociclib 100 mg/1 | Tablet, Film coatedOral | U.S. Pharmaceuticals | 63539-486 |
| Ibrancepalbociclib | Palbociclib 125 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-0688 |
| Ibrancepalbociclib | Palbociclib 100 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-0486 |
| Ibrancepalbociclib | Palbociclib 75 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-0284 |