FDA.reportPublic FDA data

Jesduvroq

Product NDC
0173-0897
11-digit product format
001730897
Labeler code
0173
Product ID
0173-0897_d52a823a-35bd-4c6a-a016-4b4f21a43d7d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
daprodustat
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
GlaxoSmithKline LLC
Application
NDA216951
Marketing category
NDA
Marketing start
2023-02-01
Marketing end
2027-01-31
Substance
DAPRODUSTAT
Active strength
1 mg/1
Pharmacologic classes
Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors [MoA], Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Jesduvroq

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DAPRODUSTAT1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJVR38ZM64B
Rxcui2628215, 2628221, 2628223, 2628225, 2628227, 2628229, 2628231, 2628233, 2628235, 2628237

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2f584af4-e42b-43ed-abb3-e47eedb1b0c0Product name120231002

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0173-0897-132025-03-13C16284748780-12cef2736-8a49-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use JESDUVROQ safely and effectively. See full prescribing information for JESDUVROQ. JESDUVROQ (daprodustat) tablets, for oral use Initial U.S. Approval: 2023
0173-0897-562025-03-13C16284748780-12cef2736-8a49-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use JESDUVROQ safely and effectively. See full prescribing information for JESDUVROQ. JESDUVROQ (daprodustat) tablets, for oral use Initial U.S. Approval: 2023
0173-0897-132025-01-30C16284748780-12cef2736-8a49-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use JESDUVROQ safely and effectively. See full prescribing information for JESDUVROQ. JESDUVROQ (daprodustat) tablets, for oral use Initial U.S. Approval: 2023
0173-0897-562025-01-30C16284748780-12cef2736-8a49-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use JESDUVROQ safely and effectively. See full prescribing information for JESDUVROQ. JESDUVROQ (daprodustat) tablets, for oral use Initial U.S. Approval: 2023

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0173-0897-13Jesduvroq30 in 1 BOTTLETABLET, FILM COATED305
0173-0897-56Jesduvroq10 in 1 CARTONTABLET, FILM COATED105
0173-0897-56Jesduvroq10 in 1 BLISTER PACKTABLET, FILM COATED105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0173-0897-13EA - Each0173-08979083f4e4-7808-4e14-a832-b66095ddc62912023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0173-0897JESDUVROQ (DAPRODUSTAT) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]5Current NDC, 3 package rows20250316_d82aa06e-5a33-4844-99b7-4701313455a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2628215daprodustat 1 MG Oral TabletPSNd82aa06e-5a33-4844-99b7-4701313455a45
2628223daprodustat 2 MG Oral TabletPSNd82aa06e-5a33-4844-99b7-4701313455a45
2628227daprodustat 4 MG Oral TabletPSNd82aa06e-5a33-4844-99b7-4701313455a45
2628231daprodustat 6 MG Oral TabletPSNd82aa06e-5a33-4844-99b7-4701313455a45
2628235daprodustat 8 MG Oral TabletPSNd82aa06e-5a33-4844-99b7-4701313455a45
2628221Jesduvroq 1 MG Oral TabletPSNd82aa06e-5a33-4844-99b7-4701313455a45
2628225Jesduvroq 2 MG Oral TabletPSNd82aa06e-5a33-4844-99b7-4701313455a45
2628229Jesduvroq 4 MG Oral TabletPSNd82aa06e-5a33-4844-99b7-4701313455a45
2628233Jesduvroq 6 MG Oral TabletPSNd82aa06e-5a33-4844-99b7-4701313455a45
2628237Jesduvroq 8 MG Oral TabletPSNd82aa06e-5a33-4844-99b7-4701313455a45
2628221daprodustat 1 MG Oral Tablet [Jesduvroq]SBDd82aa06e-5a33-4844-99b7-4701313455a45
2628225daprodustat 2 MG Oral Tablet [Jesduvroq]SBDd82aa06e-5a33-4844-99b7-4701313455a45
2628229daprodustat 4 MG Oral Tablet [Jesduvroq]SBDd82aa06e-5a33-4844-99b7-4701313455a45
2628233daprodustat 6 MG Oral Tablet [Jesduvroq]SBDd82aa06e-5a33-4844-99b7-4701313455a45
2628237daprodustat 8 MG Oral Tablet [Jesduvroq]SBDd82aa06e-5a33-4844-99b7-4701313455a45
2628215daprodustat 1 MG Oral TabletSCDd82aa06e-5a33-4844-99b7-4701313455a45
2628223daprodustat 2 MG Oral TabletSCDd82aa06e-5a33-4844-99b7-4701313455a45
2628227daprodustat 4 MG Oral TabletSCDd82aa06e-5a33-4844-99b7-4701313455a45
2628231daprodustat 6 MG Oral TabletSCDd82aa06e-5a33-4844-99b7-4701313455a45
2628235daprodustat 8 MG Oral TabletSCDd82aa06e-5a33-4844-99b7-4701313455a45
2628221Jesduvroq 1 MG Oral TabletSYd82aa06e-5a33-4844-99b7-4701313455a45
2628225Jesduvroq 2 MG Oral TabletSYd82aa06e-5a33-4844-99b7-4701313455a45
2628229Jesduvroq 4 MG Oral TabletSYd82aa06e-5a33-4844-99b7-4701313455a45
2628233Jesduvroq 6 MG Oral TabletSYd82aa06e-5a33-4844-99b7-4701313455a45
2628237Jesduvroq 8 MG Oral TabletSYd82aa06e-5a33-4844-99b7-4701313455a45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0173-0897-130017308971330 TABLET, FILM COATED in 1 BOTTLE (0173-0897-13) 2023-02-012027-01-31NoNoHistorical
0173-0897-560017308975610 in 1 CARTONHistorical