FDA.reportPublic FDA data

Vonjo

Product NDC
72482-100
11-digit product format
724820100
Labeler code
72482
Product ID
72482-100_48c817fd-c902-46bb-b81c-10215d72a0a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pacritinib
Dosage form
CAPSULE
Route
ORAL
Labeler
Sobi, Inc.
Application
NDA208712
Marketing category
NDA
Marketing start
2022-02-28
Substance
PACRITINIB
Active strength
100 mg/1
Pharmacologic classes
Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Janus Kinase Inhibitors [MoA], Kinase Inhibitor [EPC], Organic Cation Transporter 1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Tyrosine Kinase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PACRITINIB100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG22N65IL3O
Rxcui2595248, 2595254

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
76edc15e-8ab1-4e63-b6e9-054435d79bd7Product name120221212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72482-100-122024-01-30C16284748780-11030e365-4da3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VONJO safely and effectively. See full prescribing information for VONJO. VONJO ® (pacritinib) capsules, for oral use Initial U.S. Approval: 2022
72482-100-122024-01-30C16284748780-11030e365-4da3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VONJO safely and effectively. See full prescribing information for VONJO. VONJO ® (pacritinib) capsules, for oral use Initial U.S. Approval: 2022
72482-100-122024-01-30C16284748780-11030e365-4da3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VONJO safely and effectively. See full prescribing information for VONJO. VONJO ® (pacritinib) capsules, for oral use Initial U.S. Approval: 2022

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72482-100-12Vonjo40 in 1 BOXCAPSULE409
72482-100-12Vonjo1 in 1 CARTONCAPSULE19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72482-100-12EA - Each72482-1000d6748b0-93c7-4cf6-913b-96b4c4ebb35112022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72482-100VONJO (PACRITINIB) CAPSULE [SOBI, INC.]6Current NDC, Legacy NDC, 2 package rows20241128_4b5ab444-0e1a-4984-99db-76ad11a298ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2595248pacritinib 100 MG Oral CapsulePSN4b5ab444-0e1a-4984-99db-76ad11a298ee9
2595254VONJO 100 MG Oral CapsulePSN4b5ab444-0e1a-4984-99db-76ad11a298ee9
2595254pacritinib 100 MG Oral Capsule [Vonjo]SBD4b5ab444-0e1a-4984-99db-76ad11a298ee9
2595248pacritinib 100 MG Oral CapsuleSCD4b5ab444-0e1a-4984-99db-76ad11a298ee9
2595248pacritinib 100 MG (as pacritinib citrate 141 MG) Oral CapsuleSY4b5ab444-0e1a-4984-99db-76ad11a298ee9
2595254Vonjo 100 MG Oral CapsuleSY4b5ab444-0e1a-4984-99db-76ad11a298ee9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72482-100-127248201001240 CARTON in 1 BOX (72482-100-12) / 1 BOTTLE in 1 CARTON / 120 CAPSULE in 1 BOTTLE40 carton2022-02-280000-00-00NoNoCurrent