FDA.reportPublic FDA data

GRAFAPEX

Product NDC
59137-335
11-digit product format
591370335
Labeler code
59137
Product ID
59137-335_2d06b03c-17aa-0492-e063-6294a90abd8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
treosulfan
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Medexus Pharma, Inc.
Application
NDA214759
Marketing category
NDA
Marketing start
2025-01-28
Substance
TREOSULFAN
Active strength
1000 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N214759-001GRAFAPEXTREOSULFAN1GM/VIALPOWDER / INTRAVENOUSRLD, RS2025-01-21
N214759-002GRAFAPEXTREOSULFAN5GM/VIALPOWDER / INTRAVENOUSRLD, RS2025-01-21

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N214759-00171991622026-10-12U-41422025-02-20
N214759-00271991622026-10-12U-41422025-02-20

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N214759-001NCE2030-01-21
N214759-001ODE-5132032-01-21
N214759-001ODE-5142032-01-21
N214759-002NCE2030-01-21
N214759-002ODE-5132032-01-21
N214759-002ODE-5142032-01-21

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
2026-02-19 14:30 UTC2026-02N214759-001GRAFAPEX1GM/VIALPOWDER / INTRAVENOUSRLD, RS2025-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214759-002GRAFAPEX5GM/VIALPOWDER / INTRAVENOUSRLD, RS2025-01-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214759-001GRAFAPEX1GM/VIALPOWDER / INTRAVENOUSRLD, RS2025-01-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214759-002GRAFAPEX5GM/VIALPOWDER / INTRAVENOUSRLD, RS2025-01-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N214759-001GRAFAPEX1GM/VIALPOWDER / INTRAVENOUSRLD, RS2025-01-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214759-002GRAFAPEX5GM/VIALPOWDER / INTRAVENOUSRLD, RS2025-01-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214759-001GRAFAPEX1GM/VIALPOWDER / INTRAVENOUSRLD, RS2025-01-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214759-002GRAFAPEX5GM/VIALPOWDER / INTRAVENOUSRLD, RS2025-01-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214759-001GRAFAPEX1GM/VIALPOWDER / INTRAVENOUSRLD, RS2025-01-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214759-002GRAFAPEX5GM/VIALPOWDER / INTRAVENOUSRLD, RS2025-01-21b8a1b40f171c…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N214759-001GRAFAPEX1GM/VIALPOWDER / INTRAVENOUSRLD, RS2025-01-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N214759-002GRAFAPEX5GM/VIALPOWDER / INTRAVENOUSRLD, RS2025-01-21a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N214759-00171991622026-03-21U-41422025-02-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214759-00271991622026-03-21U-41422025-02-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214759-00171991622026-03-21U-41422025-02-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214759-00271991622026-03-21U-41422025-02-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08N214759-00171991622026-03-21U-41422025-02-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214759-00271991622026-03-21U-41422025-02-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214759-00171991622025-10-12U-41422025-02-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214759-00271991622025-10-12U-41422025-02-20fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N214759-00171991622026-10-12U-41422025-02-20a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N214759-00271991622026-10-12U-41422025-02-20a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N214759-001NCE2030-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214759-001ODE-5132032-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214759-001ODE-5142032-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214759-002NCE2030-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214759-002ODE-5132032-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214759-002ODE-5142032-01-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214759-001NCE2030-01-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214759-001ODE-5132032-01-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214759-001ODE-5142032-01-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214759-002NCE2030-01-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214759-002ODE-5132032-01-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214759-002ODE-5142032-01-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N214759-001NCE2030-01-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214759-001ODE-5132032-01-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214759-001ODE-5142032-01-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214759-002NCE2030-01-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214759-002ODE-5132032-01-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214759-002ODE-5142032-01-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214759-001NCE2030-01-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214759-002NCE2030-01-21fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N214759-001NCE2030-01-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N214759-001ODE-5132032-01-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N214759-001ODE-5142032-01-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N214759-002NCE2030-01-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N214759-002ODE-5132032-01-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N214759-002ODE-5142032-01-21a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
GRAFAPEX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TREOSULFAN1000 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
CO61ER3EPIInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2703570Internal RxNorm lookup
2703575Internal RxNorm lookup
2703577Internal RxNorm lookup
2703579Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2d06b03c-17aa-0492-e063-6294a90abd8fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59137-335-01GRAFAPEX1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,11
59137-335-01GRAFAPEX1 g in 1 VIALINJECTION, POWDER, LYOPHILIZED,11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59137-335-01EA - Each59137-33562f341e5-cae2-4b6e-8124-38075164818212025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59137-335GRAFAPEX (TREOSULFAN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEDEXUS PHARMA, INC.]1Current NDC, 2 package rows20250202_2d06b03c-17aa-0492-e063-6294a90abd8f.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
GRAFAPEXTREOSULFANMedexus Pharma, Inc.2d06b03c-17aa-0492-e063-6294a90abd8f2025-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 214759
application number: NDA214759
ndc (product): 59137-335

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2703575GRAFAPEX 1 GM InjectionPSN2d06b03c-17aa-0492-e063-6294a90abd8f1
2703579GRAFAPEX 5 GM InjectionPSN2d06b03c-17aa-0492-e063-6294a90abd8f1
2703570treosulfan 1 GM InjectionPSN2d06b03c-17aa-0492-e063-6294a90abd8f1
2703577treosulfan 5 GM InjectionPSN2d06b03c-17aa-0492-e063-6294a90abd8f1
2703575treosulfan 1000 MG Injection [Grafapex]SBD2d06b03c-17aa-0492-e063-6294a90abd8f1
2703579treosulfan 5000 MG Injection [Grafapex]SBD2d06b03c-17aa-0492-e063-6294a90abd8f1
2703570treosulfan 1000 MG InjectionSCD2d06b03c-17aa-0492-e063-6294a90abd8f1
2703577treosulfan 5000 MG InjectionSCD2d06b03c-17aa-0492-e063-6294a90abd8f1
2703575Grafapex 1 GM InjectionSY2d06b03c-17aa-0492-e063-6294a90abd8f1
2703575Grafapex 1000 MG InjectionSY2d06b03c-17aa-0492-e063-6294a90abd8f1
2703579Grafapex 5 GM InjectionSY2d06b03c-17aa-0492-e063-6294a90abd8f1
2703579Grafapex 5000 MG InjectionSY2d06b03c-17aa-0492-e063-6294a90abd8f1
2703570treosulfan 1 GM InjectionSY2d06b03c-17aa-0492-e063-6294a90abd8f1
2703577treosulfan 5 GM InjectionSY2d06b03c-17aa-0492-e063-6294a90abd8f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59137-335-01591370335011 VIAL in 1 CARTON (59137-335-01) / 1 g in 1 VIAL1 vial2025-01-28NoNoCurrent