inrebic

Generic: fedratinib hydrochloride

Labeler: celgene corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name inrebic
Generic Name fedratinib hydrochloride
Labeler celgene corporation
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fedratinib hydrochloride 100 mg/1

Manufacturer
Celgene Corporation

Identifiers & Regulatory

Product NDC 59572-720
Product ID 59572-720_4dfbf0f3-52f5-4461-b645-b8eb8846a8e1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA212327
Listing Expiration 2026-12-31
Marketing Start 2019-08-16

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59572720
Hyphenated Format 59572-720

Supplemental Identifiers

RxCUI
2197495 2197501
UNII
UH9J2HBQWJ

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 inrebic (source: ndc)
Generic Name fedratinib hydrochloride (source: ndc)
Application Number NDA212327 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 120 CAPSULE in 1 BOTTLE, PLASTIC (59572-720-12)
source: ndc

Packages (1)

59572-720-12 120 CAPSULE in 1 BOTTLE, PLASTIC (59572-720-12)

Ingredients (1)

fedratinib hydrochloride (100 mg/1)

Linked Drug Pages (1)

Inrebic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4dfbf0f3-52f5-4461-b645-b8eb8846a8e1", "openfda": {"unii": ["UH9J2HBQWJ"], "rxcui": ["2197495", "2197501"], "spl_set_id": ["f0f55a2a-4e0c-4cba-8571-03e1424486d7"], "manufacturer_name": ["Celgene Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 CAPSULE in 1 BOTTLE, PLASTIC (59572-720-12)", "package_ndc": "59572-720-12", "marketing_start_date": "20190816"}], "brand_name": "Inrebic", "product_id": "59572-720_4dfbf0f3-52f5-4461-b645-b8eb8846a8e1", "dosage_form": "CAPSULE", "product_ndc": "59572-720", "generic_name": "Fedratinib Hydrochloride", "labeler_name": "Celgene Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Inrebic", "active_ingredients": [{"name": "FEDRATINIB HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "NDA212327", "marketing_category": "NDA", "marketing_start_date": "20190816", "listing_expiration_date": "20261231"}