ibrance

Generic: palbociclib

Labeler: pfizer laboratories div pfizer inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibrance
Generic Name palbociclib
Labeler pfizer laboratories div pfizer inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

palbociclib 75 mg/1

Manufacturer
Pfizer Laboratories Div Pfizer Inc

Identifiers & Regulatory

Product NDC 0069-0284
Product ID 0069-0284_01800bda-3788-40c5-976b-c054dda1c0b2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA212436
Listing Expiration 2027-12-31
Marketing Start 2020-03-30

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 00690284
Hyphenated Format 0069-0284

Supplemental Identifiers

RxCUI
2284102 2284104 2284105 2284106 2284107 2284108
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 NDA212436 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 3 DOSE PACK in 1 CARTON (0069-0284-03) / 7 TABLET, FILM COATED in 1 DOSE PACK (0069-0284-07)
source: ndc

Packages (1)

0069-0284-03 3 DOSE PACK in 1 CARTON (0069-0284-03) / 7 TABLET, FILM COATED in 1 DOSE PACK (0069-0284-07)

Ingredients (1)

palbociclib (75 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": "01800bda-3788-40c5-976b-c054dda1c0b2", "openfda": {"nui": ["N0000175605", "N0000175082", "N0000190114"], "unii": ["G9ZF61LE7G"], "rxcui": ["2284102", "2284104", "2284105", "2284106", "2284107", "2284108"], "spl_set_id": ["fecbdd7d-b729-41b5-9872-231b8fe104ce"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Kinase Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]"], "manufacturer_name": ["Pfizer Laboratories Div Pfizer Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 DOSE PACK in 1 CARTON (0069-0284-03)  / 7 TABLET, FILM COATED in 1 DOSE PACK (0069-0284-07)", "package_ndc": "0069-0284-03", "marketing_start_date": "20200330"}], "brand_name": "Ibrance", "product_id": "0069-0284_01800bda-3788-40c5-976b-c054dda1c0b2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 3A Inhibitors [MoA]", "Kinase Inhibitor [EPC]", "Kinase Inhibitors [MoA]"], "product_ndc": "0069-0284", "generic_name": "palbociclib", "labeler_name": "Pfizer Laboratories Div Pfizer Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibrance", "active_ingredients": [{"name": "PALBOCICLIB", "strength": "75 mg/1"}], "application_number": "NDA212436", "marketing_category": "NDA", "marketing_start_date": "20200330", "listing_expiration_date": "20271231"}