FDA.reportPublic FDA data

Selexipag TITRATION PACK

Product NDC
70710-1653
11-digit product format
707101653
Labeler code
70710
Product ID
70710-1653_96a3e445-2cb7-4fb5-b95b-3f71f5f72504
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Selexipag
Dosage form
KIT
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA214302
Marketing category
ANDA
Marketing start
2025-02-14
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Selexipag TITRATION PACK
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5EXC0E384L
Rxcui1729007, 1729027, 1729031, 1729045, 1729051, 1729055, 1729059, 1729063, 1729075

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3940235d-2369-40fe-94e3-68f58494a1a8Product name320250627

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1551-8Selexipag TITRATION PACK140 in 1 BOTTLETABLET, FILM COATED140200 ug3
70710-1554-6Selexipag TITRATION PACK60 in 1 BOTTLETABLET, FILM COATED60800 ug3
70710-1653-7Selexipag TITRATION PACK1 in 1 CARTONKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1653SELEXIPAG TABLET, FILM COATED SELEXIPAG TITRATION PACK (SELEXIPAG) KIT [ZYDUS PHARMACEUTICALS (USA) INC.]3Current NDC, 3 package rows20250215_c604e181-e336-4194-bf96-f65dd164d461.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1729075{140 (selexipag 0.2 MG Oral Tablet) / 60 (selexipag 0.8 MG Oral Tablet) } PackGPCKc604e181-e336-4194-bf96-f65dd164d4613
1729007selexipag 1000 MCG Oral TabletPSNc604e181-e336-4194-bf96-f65dd164d4613
1729027selexipag 1200 MCG Oral TabletPSNc604e181-e336-4194-bf96-f65dd164d4613
1729031selexipag 1400 MCG Oral TabletPSNc604e181-e336-4194-bf96-f65dd164d4613
1729045selexipag 1600 MCG Oral TabletPSNc604e181-e336-4194-bf96-f65dd164d4613
1729075selexipag 200 MCG (140), selexipag 800 MCG (60) Oral Tablet Titration PackPSNc604e181-e336-4194-bf96-f65dd164d4613
1729051selexipag 200 MCG Oral TabletPSNc604e181-e336-4194-bf96-f65dd164d4613
1729055selexipag 400 MCG Oral TabletPSNc604e181-e336-4194-bf96-f65dd164d4613
1729059selexipag 600 MCG Oral TabletPSNc604e181-e336-4194-bf96-f65dd164d4613
1729063selexipag 800 MCG Oral TabletPSNc604e181-e336-4194-bf96-f65dd164d4613
1729051selexipag 0.2 MG Oral TabletSCDc604e181-e336-4194-bf96-f65dd164d4613
1729055selexipag 0.4 MG Oral TabletSCDc604e181-e336-4194-bf96-f65dd164d4613
1729059selexipag 0.6 MG Oral TabletSCDc604e181-e336-4194-bf96-f65dd164d4613
1729063selexipag 0.8 MG Oral TabletSCDc604e181-e336-4194-bf96-f65dd164d4613
1729007selexipag 1 MG Oral TabletSCDc604e181-e336-4194-bf96-f65dd164d4613
1729027selexipag 1.2 MG Oral TabletSCDc604e181-e336-4194-bf96-f65dd164d4613
1729031selexipag 1.4 MG Oral TabletSCDc604e181-e336-4194-bf96-f65dd164d4613
1729045selexipag 1.6 MG Oral TabletSCDc604e181-e336-4194-bf96-f65dd164d4613
1729075{140 (selexipag 200 MCG Oral Tablet) / 60 (selexipag 800 MCG Oral Tablet) } PackSYc604e181-e336-4194-bf96-f65dd164d4613
1729007selexipag 1000 MCG Oral TabletSYc604e181-e336-4194-bf96-f65dd164d4613
1729027selexipag 1200 MCG Oral TabletSYc604e181-e336-4194-bf96-f65dd164d4613
1729031selexipag 1400 MCG Oral TabletSYc604e181-e336-4194-bf96-f65dd164d4613
1729045selexipag 1600 MCG Oral TabletSYc604e181-e336-4194-bf96-f65dd164d4613
1729051selexipag 200 MCG Oral TabletSYc604e181-e336-4194-bf96-f65dd164d4613
1729055selexipag 400 MCG Oral TabletSYc604e181-e336-4194-bf96-f65dd164d4613
1729059selexipag 600 MCG Oral TabletSYc604e181-e336-4194-bf96-f65dd164d4613
1729063selexipag 800 MCG Oral TabletSYc604e181-e336-4194-bf96-f65dd164d4613

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70710-1551-870710155108140 in 1 BOTTLEHistorical
70710-1554-67071015540660 in 1 BOTTLEHistorical
70710-1653-7707101653071 KIT in 1 CARTON (70710-1653-7) * 1 BOTTLE in 1 CARTON / 140 TABLET, FILM COATED in 1 BOTTLE (70710-1551-8) * 1 BOTTLE in 1 CARTON / 60 TABLET, FILM COATED in 1 BOTTLE (70710-1554-6) 1 kit2025-02-14NoNoCurrent