Ibrance (palbociclib) NDC 0069-0284

NDC codes

FDA NDC Directory

Product NDC (as listed)0069-0284Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00069-0284Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0069-0284-03	00069028403	3 DOSE PACK in 1 CARTON (0069-0284-03) / 7 TABLET, FILM COATED in 1 DOSE PACK (0069-0284-07)Marketed from Mar 30, 2020

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: Tablet, Film coated
Route: Oral
Labeler: Pfizer Laboratories Div Pfizer Inc
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 212436
Marketing start: Mar 30, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Cytochrome P450 3A Inhibitors (Mechanism)Kinase Inhibitors (Mechanism)
Identifiers: Product ID 0069-0284_0bf98e9e-7794-47ec-a88f-2fb726c7861aSPL ID 0bf98e9e-7794-47ec-a88f-2fb726c7861aSPL set ID fecbdd7d-b729-41b5-9872-231b8fe104ceRxCUI 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

N400069028403 followed by a unit qualifier and the quantity

Package 00069-0284-03. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under NDA 212436

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 212436
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 75 mg/1	Tablet, Film coatedOral	U.S. Pharmaceuticals	63539-284
Ibrancepalbociclib	Palbociclib 100 mg/1	Tablet, Film coatedOral	Pfizer Laboratories Div Pfizer Inc	0069-0486