cibinqo

Generic: abrocitinib

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

Drug Facts

Product Profile

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

abrocitinib 100 mg/1

Manufacturer
Pfizer Laboratories Div Pfizer Inc

Identifiers & Regulatory

Product NDC 0069-0335
Product ID 0069-0335_d85989f4-41dc-4e3a-a0fa-759b68e1130c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA213871
Listing Expiration 2026-12-31
Marketing Start 2022-02-24

Pharmacologic Class

Established (EPC)
janus kinase inhibitor [epc]
Mechanism of Action
janus kinase inhibitors [moa] p-glycoprotein inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00690335
Hyphenated Format 0069-0335

Supplemental Identifiers

RxCUI
2591481 2591487 2591489 2591491 2591493 2591495
UPC
0300690235301 0300690335308 0300690435305
UNII
73SM5SF3OR
NUI
N0000190858 N0000190857 N0000185503

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 cibinqo (source: ndc)
Generic Name abrocitinib (source: ndc)
Application Number NDA213871 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (0069-0335-30)
source: ndc

Packages (1)

0069-0335-30 30 TABLET, FILM COATED in 1 BOTTLE (0069-0335-30)

Ingredients (1)

abrocitinib (100 mg/1)

Linked Drug Pages (1)

Cibinqo ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d85989f4-41dc-4e3a-a0fa-759b68e1130c", "openfda": {"nui": ["N0000190858", "N0000190857", "N0000185503"], "upc": ["0300690235301", "0300690335308", "0300690435305"], "unii": ["73SM5SF3OR"], "rxcui": ["2591481", "2591487", "2591489", "2591491", "2591493", "2591495"], "spl_set_id": ["3f6d6fcd-e9f9-42c8-bfa2-bb2cfc9ed258"], "pharm_class_epc": ["Janus Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Janus Kinase Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "manufacturer_name": ["Pfizer Laboratories Div Pfizer Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0069-0335-30)", "package_ndc": "0069-0335-30", "marketing_start_date": "20220224"}], "brand_name": "Cibinqo", "product_id": "0069-0335_d85989f4-41dc-4e3a-a0fa-759b68e1130c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Janus Kinase Inhibitor [EPC]", "Janus Kinase Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "0069-0335", "generic_name": "abrocitinib", "labeler_name": "Pfizer Laboratories Div Pfizer Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cibinqo", "active_ingredients": [{"name": "ABROCITINIB", "strength": "100 mg/1"}], "application_number": "NDA213871", "marketing_category": "NDA", "marketing_start_date": "20220224", "listing_expiration_date": "20261231"}