Prescription drug · NDA
Ibrance (Palbociclib) NDC 0069-0187
Palbociclib 75 mg/1 · Capsule · Oral · Pfizer Laboratories Div Pfizer Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0069-0187-21 | 00069018721 | 21 CAPSULE in 1 BOTTLE (0069-0187-21)Marketed from Feb 3, 2015 |
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)
- Ibrance
- Generic name (nonproprietary)
- palbociclib
- Active ingredients
- Palbociclib — 75 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Pfizer Laboratories Div Pfizer IncNDC labeler code 0069
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 207103
- Marketing start
- Marketing end
- Other FDA classes
- Cytochrome P450 3A Inhibitors (Mechanism)Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 0069-0187_7dcc9b87-0aa4-4a00-aced-96be3553e8acSPL ID 7dcc9b87-0aa4-4a00-aced-96be3553e8acSPL set ID e0e6412f-50b4-4fd4-9364-62818d121a07RxCUI 1601380, 1601386, 1601388, 1601390, 1601392, 1601394UNII G9ZF61LE7GUPC 0300690188218, 0300690189215, 0300690187211
- 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
N400069018721followed by a unit qualifier and the quantityPackage 00069-0187-21. 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.
About NDC 0069-0187
- What is NDC 0069-0187?
- 0069-0187 is the product NDC for Ibrance (palbociclib), Palbociclib 75 mg/1 capsule, listed with the FDA by Pfizer Laboratories Div Pfizer Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ibrance (Palbociclib).
- What is the active ingredient?
- Palbociclib.
- Who is the labeler?
- Pfizer Laboratories Div Pfizer Inc, NDC labeler code 0069. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ibrance?
- 8 other product NDCs are listed under this name. See all Ibrance NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ibrance products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ibrancepalbociclib | Palbociclib 100 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-0486 | 00069-0486-03 |
| Ibrancepalbociclib | Palbociclib 75 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-0284 | 00069-0284-03 |
| Ibrancepalbociclib | Palbociclib 75 mg/1 | Tablet, Film coatedOral | U.S. Pharmaceuticals | 63539-284 | 63539-0284-03 |
| Ibrancepalbociclib | Palbociclib 125 mg/1 | Tablet, Film coatedOral | U.S. Pharmaceuticals | 63539-688 | 63539-0688-03 |
| Ibrancepalbociclib | Palbociclib 100 mg/1 | Tablet, Film coatedOral | U.S. Pharmaceuticals | 63539-486 | 63539-0486-03 |
| Ibrancepalbociclib | Palbociclib 125 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-0688 | 00069-0688-03 |
| Ibrancepalbociclib | Palbociclib 100 mg/1 | CapsuleOral | Pfizer Laboratories Div Pfizer Inc | 0069-0188 | 00069-0188-21 |
| Ibrancepalbociclib | Palbociclib 125 mg/1 | CapsuleOral | Pfizer Laboratories Div Pfizer Inc | 0069-0189 | 00069-0189-21 |
Other NDCs under NDA 207103
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 100 mg/1 | CapsuleOral | Pfizer Laboratories Div Pfizer Inc | 0069-0188 |
| Ibrancepalbociclib | Palbociclib 125 mg/1 | CapsuleOral | Pfizer Laboratories Div Pfizer Inc | 0069-0189 |