FDA.reportPublic FDA data

NOURIANZ

Product NDC
42747-604
11-digit product format
427470604
Labeler code
42747
Product ID
42747-604_607b4223-661d-45e0-8209-99c5ba62d5c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
istradefylline
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Kyowa Kirin, Inc.
Application
NDA022075
Marketing category
NDA
Marketing start
2019-08-27
Substance
ISTRADEFYLLINE
Active strength
40 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISTRADEFYLLINE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2GZ0LIK7T4
Rxcui2199020, 2199026, 2199028, 2199030

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
927c1293-c653-4a79-870b-0a7ff453a631Product name120200213

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42747-604-07NOURIANZ1 in 1 BOXTABLET, FILM COATED16
42747-604-07NOURIANZ7 in 1 BLISTER PACKTABLET, FILM COATED76
42747-604-90NOURIANZ90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42747-604-90EA - Each42747-6041c3e158a-7582-4499-a585-53de20e4279812019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42747-604NOURIANZ (ISTRADEFYLLINE) TABLET, FILM COATED [KYOWA KIRIN, INC.]6Current NDC, Legacy NDC, 3 package rows20250523_a7d008cb-b273-4049-a5d2-9c6902910d58.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2199020istradefylline 20 MG Oral TabletPSNa7d008cb-b273-4049-a5d2-9c6902910d586
2199028istradefylline 40 MG Oral TabletPSNa7d008cb-b273-4049-a5d2-9c6902910d586
2199026NOURIANZ 20 MG Oral TabletPSNa7d008cb-b273-4049-a5d2-9c6902910d586
2199030NOURIANZ 40 MG Oral TabletPSNa7d008cb-b273-4049-a5d2-9c6902910d586
2199026istradefylline 20 MG Oral Tablet [Nourianz]SBDa7d008cb-b273-4049-a5d2-9c6902910d586
2199030istradefylline 40 MG Oral Tablet [Nourianz]SBDa7d008cb-b273-4049-a5d2-9c6902910d586
2199020istradefylline 20 MG Oral TabletSCDa7d008cb-b273-4049-a5d2-9c6902910d586
2199028istradefylline 40 MG Oral TabletSCDa7d008cb-b273-4049-a5d2-9c6902910d586
2199026Nourianz 20 MG Oral TabletSYa7d008cb-b273-4049-a5d2-9c6902910d586
2199030Nourianz 40 MG Oral TabletSYa7d008cb-b273-4049-a5d2-9c6902910d586

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42747-604-07427470604071 BLISTER PACK in 1 BOX (42747-604-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2019-08-270000-00-00YesNoCurrent
42747-604-904274706049090 TABLET, FILM COATED in 1 BOTTLE (42747-604-90) 2019-08-270000-00-00NoNoCurrent