ibrance

Generic: palbociclib

Labeler: u.s. pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibrance
Generic Name palbociclib
Labeler u.s. pharmaceuticals
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

palbociclib 125 mg/1

Manufacturer
U.S. Pharmaceuticals

Identifiers & Regulatory

Product NDC 63539-189
Product ID 63539-189_fa0d4a01-f6f9-4e10-ad58-fdfd23a8ead2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA207103
Listing Expiration 2026-12-31
Marketing Start 2015-02-03

Pharmacologic Class

Established (EPC)
kinase inhibitor [epc]
Mechanism of Action
kinase inhibitors [moa] cytochrome p450 3a inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63539189
Hyphenated Format 63539-189

Supplemental Identifiers

RxCUI
1601380 1601386 1601388 1601390 1601392 1601394
UNII
G9ZF61LE7G
NUI
N0000175605 N0000175082 N0000190114

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ibrance (source: ndc)
Generic Name palbociclib (source: ndc)
Application Number NDA207103 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/1
source: ndc
Packaging
  • 21 CAPSULE in 1 BOTTLE (63539-189-11)
source: ndc

Packages (1)

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

Ingredients (1)

palbociclib (125 mg/1)

Linked Drug Pages (1)

Ibrance ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "fa0d4a01-f6f9-4e10-ad58-fdfd23a8ead2", "openfda": {"nui": ["N0000175605", "N0000175082", "N0000190114"], "unii": ["G9ZF61LE7G"], "rxcui": ["1601380", "1601386", "1601388", "1601390", "1601392", "1601394"], "spl_set_id": ["86718885-da44-4d3d-b3ca-06cbcedcffd8"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Kinase Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]"], "manufacturer_name": ["U.S. Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "21 CAPSULE in 1 BOTTLE (63539-189-11)", "package_ndc": "63539-189-11", "marketing_start_date": "20150203"}], "brand_name": "Ibrance", "product_id": "63539-189_fa0d4a01-f6f9-4e10-ad58-fdfd23a8ead2", "dosage_form": "CAPSULE", "pharm_class": ["Cytochrome P450 3A Inhibitors [MoA]", "Kinase Inhibitor [EPC]", "Kinase Inhibitors [MoA]"], "product_ndc": "63539-189", "generic_name": "palbociclib", "labeler_name": "U.S. Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibrance", "active_ingredients": [{"name": "PALBOCICLIB", "strength": "125 mg/1"}], "application_number": "NDA207103", "marketing_category": "NDA", "marketing_start_date": "20150203", "listing_expiration_date": "20261231"}