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 CAPSULE
Routes
ORAL
Active Ingredients

palbociclib 100 mg/1

Manufacturer
Pfizer Laboratories Div Pfizer Inc

Identifiers & Regulatory

Product NDC 0069-0188
Product ID 0069-0188_fb858b80-8bd4-43a6-8871-9819a35ca03f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA207103
Listing Expiration 2027-12-31
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 00690188
Hyphenated Format 0069-0188

Supplemental Identifiers

RxCUI
1601380 1601386 1601388 1601390 1601392 1601394
UPC
0300690188218 0300690189215 0300690187211
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
  • 100 mg/1
source: ndc
Packaging
  • 21 CAPSULE in 1 BOTTLE (0069-0188-21)
source: ndc

Packages (1)

0069-0188-21 21 CAPSULE in 1 BOTTLE (0069-0188-21)

Ingredients (1)

palbociclib (100 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": "fb858b80-8bd4-43a6-8871-9819a35ca03f", "openfda": {"nui": ["N0000175605", "N0000175082", "N0000190114"], "upc": ["0300690188218", "0300690189215", "0300690187211"], "unii": ["G9ZF61LE7G"], "rxcui": ["1601380", "1601386", "1601388", "1601390", "1601392", "1601394"], "spl_set_id": ["e0e6412f-50b4-4fd4-9364-62818d121a07"], "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": "21 CAPSULE in 1 BOTTLE (0069-0188-21)", "package_ndc": "0069-0188-21", "marketing_start_date": "20150203"}], "brand_name": "Ibrance", "product_id": "0069-0188_fb858b80-8bd4-43a6-8871-9819a35ca03f", "dosage_form": "CAPSULE", "pharm_class": ["Cytochrome P450 3A Inhibitors [MoA]", "Kinase Inhibitor [EPC]", "Kinase Inhibitors [MoA]"], "product_ndc": "0069-0188", "generic_name": "palbociclib", "labeler_name": "Pfizer Laboratories Div Pfizer Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibrance", "active_ingredients": [{"name": "PALBOCICLIB", "strength": "100 mg/1"}], "application_number": "NDA207103", "marketing_category": "NDA", "marketing_start_date": "20150203", "listing_expiration_date": "20271231"}