NDC 63539-189

Ibrance

Palbociclib

Ibrance is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by U.s. Pharmaceuticals. The primary component is Palbociclib.

• Product ID: 63539-189_8720b986-1c77-4b3e-b18e-62213aab1853
• NDC: 63539-189
• Product Type: Human Prescription Drug
• Proprietary Name: Ibrance
• Generic Name: Palbociclib
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2015-02-03
• Marketing Category: NDA / NDA
• Application Number: NDA207103
• Labeler Name: U.S. Pharmaceuticals
• Substance Name: PALBOCICLIB
• Active Ingredient Strength: 125 mg/1
• Pharm Classes: Kinase Inhibitor [EPC],Kinase Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 63539-189-11

21 CAPSULE in 1 BOTTLE (63539-189-11)

• Marketing Start Date: 2015-02-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63539-189-11 [63539018911]

Ibrance CAPSULE

• Marketing Category: NDA
• Application Number: NDA207103
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-02-03

Drug Details

Active Ingredients

Ingredient	Strength
PALBOCICLIB	125 mg/1

OpenFDA Data

• SPL SET ID: 86718885-da44-4d3d-b3ca-06cbcedcffd8
• Manufacturer:
  • U.S. Pharmaceuticals
• UNII:
  • G9ZF61LE7G
• RxNorm Concept Unique ID - RxCUI:
  • 1601380
  • 1601392
  • 1601390
  • 1601386
  • 1601394
  • 1601388

Pharmacological Class

• Kinase Inhibitor [EPC]
• Kinase Inhibitors [MoA]
• Cytochrome P450 3A Inhibitors [MoA]

NDC Crossover Matching brand name "Ibrance" or generic name "Palbociclib"

NDC	Brand Name	Generic Name
0069-0187	Ibrance	palbociclib
0069-0188	Ibrance	palbociclib
0069-0189	Ibrance	palbociclib
0069-0284	Ibrance	palbociclib
0069-0486	Ibrance	palbociclib
0069-0688	Ibrance	palbociclib
63539-187	Ibrance	palbociclib
63539-188	Ibrance	palbociclib
63539-189	Ibrance	palbociclib
63539-284	Ibrance	palbociclib
63539-486	Ibrance	palbociclib
63539-688	Ibrance	palbociclib