Vonjo

Product NDC
72482-100
11-digit product format
724820100
Labeler code
72482
Product ID
72482-100_eaca3a36-2256-47c8-ae49-3a866c61a133
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N208712-001VONJOPACRITINIB CITRATEEQ 100MG BASECAPSULE / ORALRLD, RS2022-02-28

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N208712-00195739642028-05-05U-33312022-03-28
N208712-00195739642028-05-05U-33322022-03-28
N208712-00181536322029-01-17U-3331Drug substance, Drug product2022-03-28
N208712-00181536322029-01-17U-3332Drug substance, Drug product2022-03-28
N208712-00189808732030-03-25U-3331Drug substance, Drug product2022-03-28
N208712-00189808732030-03-25U-3332Drug substance, Drug product2022-03-28

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N208712-001NCE2027-02-28
N208712-001ODE-3972029-02-28

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N208712-001VONJOEQ 100MG BASECAPSULE / ORALRLD, RS2022-02-2884e616aacf4f…
2026-08-18 06:07:402026-07N208712-001VONJOEQ 100MG BASECAPSULE / ORALRLD, RS2022-02-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N208712-001VONJOEQ 100MG BASECAPSULE / ORALRLD, RS2022-02-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208712-001VONJOEQ 100MG BASECAPSULE / ORALRLD, RS2022-02-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N208712-001VONJOEQ 100MG BASECAPSULE / ORALRLD, RS2022-02-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208712-001VONJOEQ 100MG BASECAPSULE / ORALRLD, RS2022-02-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208712-001VONJOEQ 100MG BASECAPSULE / ORALRLD, RS2022-02-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208712-001VONJOEQ 100MG BASECAPSULE / ORALRLD, RS2022-02-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208712-001VONJOEQ 100MG BASECAPSULE / ORALRLD, RS2022-02-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208712-001VONJOEQ 100MG BASECAPSULE / ORALRLD, RS2022-02-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208712-001VONJOEQ 100MG BASECAPSULE / ORALRLD, RS2022-02-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N208712-001VONJOEQ 100MG BASECAPSULE / ORALRLD, RS2022-02-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208712-001VONJOEQ 100MG BASECAPSULE / ORALRLD, RS2022-02-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208712-001VONJOEQ 100MG BASECAPSULE / ORALRLD, RS2022-02-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N208712-001VONJOEQ 100MG BASECAPSULE / ORALRLD, RS2022-02-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N208712-001VONJOEQ 100MG BASECAPSULE / ORALRLD, RS2022-02-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N208712-001VONJOEQ 100MG BASECAPSULE / ORALRLD, RS2022-02-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N208712-001VONJOEQ 100MG BASECAPSULE / ORALRLD, RS2022-02-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N208712-001VONJOEQ 100MG BASECAPSULE / ORALRLD, RS2022-02-284b0b4de00fa7…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N208712-001VONJOEQ 100MG BASECAPSULE / ORALRLD, RS2022-02-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N208712-001VONJOEQ 100MG BASECAPSULE / ORALRLD, RS2022-02-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12N208712-001VONJOEQ 100MG BASECAPSULE / ORALRLD, RS2022-02-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N208712-001VONJOEQ 100MG BASECAPSULE / ORALRLD, RS2022-02-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N208712-001VONJOEQ 100MG BASECAPSULE / ORALRLD, RS2022-02-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N208712-001VONJOEQ 100MG BASECAPSULE / ORALRLD, RS2022-02-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N208712-001VONJOEQ 100MG BASECAPSULE / ORALRLD, RS2022-02-283f0d92c62455…
2023-05-13 08:27 UTC2023-05N208712-001VONJOEQ 100MG BASECAPSULE / ORALRLD, RS2022-02-28053a50430f4f…
2023-01-26 05:58 UTC2023-01N208712-001VONJOEQ 100MG BASECAPSULE / ORALRLD, RS2022-02-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208712-001VONJOEQ 100MG BASECAPSULE / ORALRLD, RS2022-02-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N208712-001VONJOEQ 100MG BASECAPSULE / ORALRLD, RS2022-02-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N208712-001VONJOEQ 100MG BASECAPSULE / ORALRLD, RS2022-02-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N208712-001VONJOEQ 100MG BASECAPSULE / ORALRLD, RS2022-02-28cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N208712-001VONJOEQ 100MG BASECAPSULE / ORALRLD, RS2022-02-28a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 5 · 192 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N208712-00195739642028-05-05U-33322022-03-2884e616aacf4f…
2026-09-14 22:38:342026-08N208712-00195739642028-05-05U-33312022-03-2884e616aacf4f…
2026-09-14 22:38:342026-08N208712-00181536322029-01-17U-3332Drug substance, Drug product2022-03-2884e616aacf4f…
2026-09-14 22:38:342026-08N208712-00181536322029-01-17U-3331Drug substance, Drug product2022-03-2884e616aacf4f…
2026-09-14 22:38:342026-08N208712-00189808732030-03-25U-3331Drug substance, Drug product2022-03-2884e616aacf4f…
2026-09-14 22:38:342026-08N208712-00189808732030-03-25U-3332Drug substance, Drug product2022-03-2884e616aacf4f…
2026-08-18 06:07:402026-07N208712-00195739642028-05-05U-33322022-03-28caaa826d4ba7…
2026-08-18 06:07:402026-07N208712-00195739642028-05-05U-33312022-03-28caaa826d4ba7…
2026-08-18 06:07:402026-07N208712-00181536322029-01-17U-3332Drug substance, Drug product2022-03-28caaa826d4ba7…
2026-08-18 06:07:402026-07N208712-00181536322029-01-17U-3331Drug substance, Drug product2022-03-28caaa826d4ba7…
2026-08-18 06:07:402026-07N208712-00189808732030-03-25U-3331Drug substance, Drug product2022-03-28caaa826d4ba7…
2026-08-18 06:07:402026-07N208712-00189808732030-03-25U-3332Drug substance, Drug product2022-03-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N208712-00195739642028-05-05U-33322022-03-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208712-00195739642028-05-05U-33312022-03-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208712-00181536322029-01-17U-3332Drug substance, Drug product2022-03-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208712-00181536322029-01-17U-3331Drug substance, Drug product2022-03-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208712-00189808732030-03-25U-3331Drug substance, Drug product2022-03-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208712-00189808732030-03-25U-3332Drug substance, Drug product2022-03-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208712-00195739642028-05-05U-33322022-03-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208712-00195739642028-05-05U-33312022-03-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208712-00181536322029-01-17U-3332Drug substance, Drug product2022-03-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208712-00181536322029-01-17U-3331Drug substance, Drug product2022-03-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208712-00189808732030-03-25U-3331Drug substance, Drug product2022-03-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208712-00189808732030-03-25U-3332Drug substance, Drug product2022-03-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N208712-00195739642028-05-05U-33322022-03-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208712-00195739642028-05-05U-33312022-03-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208712-00181536322029-01-17U-3332Drug substance, Drug product2022-03-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208712-00181536322029-01-17U-3331Drug substance, Drug product2022-03-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208712-00189808732030-03-25U-3331Drug substance, Drug product2022-03-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208712-00189808732030-03-25U-3332Drug substance, Drug product2022-03-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208712-00195739642028-05-05U-33322022-03-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208712-00195739642028-05-05U-33312022-03-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208712-00181536322029-01-17U-3332Drug substance, Drug product2022-03-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208712-00181536322029-01-17U-3331Drug substance, Drug product2022-03-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208712-00189808732030-03-25U-3331Drug substance, Drug product2022-03-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208712-00189808732030-03-25U-3332Drug substance, Drug product2022-03-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208712-00195739642028-05-05U-33322022-03-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208712-00195739642028-05-05U-33312022-03-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208712-00181536322029-01-17U-3332Drug substance, Drug product2022-03-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208712-00181536322029-01-17U-3331Drug substance, Drug product2022-03-28b8a1b40f171c…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 57 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N208712-001NCE2027-02-2884e616aacf4f…
2026-09-14 22:38:342026-08N208712-001ODE-3972029-02-2884e616aacf4f…
2026-08-18 06:07:402026-07N208712-001NCE2027-02-28caaa826d4ba7…
2026-08-18 06:07:402026-07N208712-001ODE-3972029-02-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N208712-001NCE2027-02-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208712-001ODE-3972029-02-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208712-001NCE2027-02-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208712-001ODE-3972029-02-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N208712-001NCE2027-02-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208712-001ODE-3972029-02-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208712-001NCE2027-02-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208712-001ODE-3972029-02-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208712-001NCE2027-02-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208712-001ODE-3972029-02-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208712-001NCE2027-02-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208712-001ODE-3972029-02-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208712-001NCE2027-02-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208712-001ODE-3972029-02-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208712-001NCE2027-02-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208712-001ODE-3972029-02-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208712-001NCE2027-02-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208712-001ODE-3972029-02-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N208712-001NCE2027-02-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N208712-001ODE-3972029-02-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208712-001NCE2027-02-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208712-001ODE-3972029-02-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208712-001NCE2027-02-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208712-001ODE-3972029-02-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N208712-001NCE2027-02-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N208712-001ODE-3972029-02-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N208712-001NCE2027-02-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05N208712-001ODE-3972029-02-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N208712-001NCE2027-02-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N208712-001NCE2027-02-285d02ea3f76ae…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N208712-001NCE2027-02-286a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N208712-001ODE-3972029-02-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N208712-001NCE2027-02-281c564ffb4f44…
2024-02-18 07:12 UTC2024-02N208712-001ODE-3972029-02-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12N208712-001NCE2027-02-28ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N208712-001ODE-3972029-02-28ea1830bbd6c7…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G22N65IL3OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2595248Internal RxNorm lookup
2595254Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4b5ab444-0e1a-4984-99db-76ad11a298eeAvailable on FDA.report

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VonjoPACRITINIBSobi, Inc.4b5ab444-0e1a-4984-99db-76ad11a298ee2026-07-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 208712
application number: NDA208712
ndc (product): 72482-100

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