Inrebic

Product NDC
59572-720
11-digit product format
595720720
Labeler code
59572
Product ID
59572-720_4707dba8-73ee-4119-805b-65c3f3a55b72
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fedratinib Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Celgene Corporation
Application
NDA212327
Marketing category
NDA
Marketing start
2019-08-16
Substance
FEDRATINIB HYDROCHLORIDE
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Inrebic
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEDRATINIB HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUH9J2HBQWJ
Rxcui2197495, 2197501

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5705395c-f2c5-40be-a8c4-cf54cf608df3Product name120200129

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59572-720-12Inrebic120 in 1 BOTTLE, PLASTICCAPSULE12011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59572-720-12EA - Each59572-720243aeb74-8dec-48c4-badd-a7afc7809fbc12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59572-720INREBIC (FEDRATINIB HYDROCHLORIDE) CAPSULE [CELGENE CORPORATION]10Current NDC, Legacy NDC, 1 package rows20250524_f0f55a2a-4e0c-4cba-8571-03e1424486d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2197495fedratinib 100 MG Oral CapsulePSNf0f55a2a-4e0c-4cba-8571-03e1424486d711
2197501INREBIC 100 MG Oral CapsulePSNf0f55a2a-4e0c-4cba-8571-03e1424486d711
2197501fedratinib 100 MG Oral Capsule [Inrebic]SBDf0f55a2a-4e0c-4cba-8571-03e1424486d711
2197495fedratinib 100 MG Oral CapsuleSCDf0f55a2a-4e0c-4cba-8571-03e1424486d711
2197495fedratinib (as fedratinib dihydrochloride 117.3 MG) 100 MG Oral CapsuleSYf0f55a2a-4e0c-4cba-8571-03e1424486d711
2197501Inrebic (as fedratinib dihydrochloride monohydrate 117.3 MG) 100 MG Oral CapsuleSYf0f55a2a-4e0c-4cba-8571-03e1424486d711
2197501Inrebic 100 MG Oral CapsuleSYf0f55a2a-4e0c-4cba-8571-03e1424486d711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59572-720-1259572072012120 CAPSULE in 1 BOTTLE, PLASTIC (59572-720-12) 120 capsule2019-08-160000-00-00NoNoCurrent