FDA.reportPublic FDA data

Selexipag TITRATION PACK

Product NDC
70771-1801
11-digit product format
707711801
Labeler code
70771
Product ID
70771-1801_e39f2aba-4f8f-49d0-82e2-ee509b830d36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Selexipag
Dosage form
KIT
Labeler
Zydus Lifesciences Limited
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
70771-1793-8Selexipag TITRATION PACK140 in 1 BOTTLETABLET, FILM COATED140200 ug2
70771-1796-6Selexipag TITRATION PACK60 in 1 BOTTLETABLET, FILM COATED60800 ug2
70771-1801-7Selexipag TITRATION PACK1 in 1 CARTONKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1801SELEXIPAG TABLET, FILM COATED SELEXIPAG TITRATION PACK (SELEXIPAG) KIT [ZYDUS LIFESCIENCES LIMITED]1Current NDC, 3 package rows20250215_ff660787-880f-4f2b-baac-fd2dbfcd79c2.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) } PackGPCKff660787-880f-4f2b-baac-fd2dbfcd79c22
1729007selexipag 1000 MCG Oral TabletPSNff660787-880f-4f2b-baac-fd2dbfcd79c22
1729027selexipag 1200 MCG Oral TabletPSNff660787-880f-4f2b-baac-fd2dbfcd79c22
1729031selexipag 1400 MCG Oral TabletPSNff660787-880f-4f2b-baac-fd2dbfcd79c22
1729045selexipag 1600 MCG Oral TabletPSNff660787-880f-4f2b-baac-fd2dbfcd79c22
1729075selexipag 200 MCG (140), selexipag 800 MCG (60) Oral Tablet Titration PackPSNff660787-880f-4f2b-baac-fd2dbfcd79c22
1729051selexipag 200 MCG Oral TabletPSNff660787-880f-4f2b-baac-fd2dbfcd79c22
1729055selexipag 400 MCG Oral TabletPSNff660787-880f-4f2b-baac-fd2dbfcd79c22
1729059selexipag 600 MCG Oral TabletPSNff660787-880f-4f2b-baac-fd2dbfcd79c22
1729063selexipag 800 MCG Oral TabletPSNff660787-880f-4f2b-baac-fd2dbfcd79c22
1729051selexipag 0.2 MG Oral TabletSCDff660787-880f-4f2b-baac-fd2dbfcd79c22
1729055selexipag 0.4 MG Oral TabletSCDff660787-880f-4f2b-baac-fd2dbfcd79c22
1729059selexipag 0.6 MG Oral TabletSCDff660787-880f-4f2b-baac-fd2dbfcd79c22
1729063selexipag 0.8 MG Oral TabletSCDff660787-880f-4f2b-baac-fd2dbfcd79c22
1729007selexipag 1 MG Oral TabletSCDff660787-880f-4f2b-baac-fd2dbfcd79c22
1729027selexipag 1.2 MG Oral TabletSCDff660787-880f-4f2b-baac-fd2dbfcd79c22
1729031selexipag 1.4 MG Oral TabletSCDff660787-880f-4f2b-baac-fd2dbfcd79c22
1729045selexipag 1.6 MG Oral TabletSCDff660787-880f-4f2b-baac-fd2dbfcd79c22
1729075{140 (selexipag 200 MCG Oral Tablet) / 60 (selexipag 800 MCG Oral Tablet) } PackSYff660787-880f-4f2b-baac-fd2dbfcd79c22
1729007selexipag 1000 MCG Oral TabletSYff660787-880f-4f2b-baac-fd2dbfcd79c22
1729027selexipag 1200 MCG Oral TabletSYff660787-880f-4f2b-baac-fd2dbfcd79c22
1729031selexipag 1400 MCG Oral TabletSYff660787-880f-4f2b-baac-fd2dbfcd79c22
1729045selexipag 1600 MCG Oral TabletSYff660787-880f-4f2b-baac-fd2dbfcd79c22
1729051selexipag 200 MCG Oral TabletSYff660787-880f-4f2b-baac-fd2dbfcd79c22
1729055selexipag 400 MCG Oral TabletSYff660787-880f-4f2b-baac-fd2dbfcd79c22
1729059selexipag 600 MCG Oral TabletSYff660787-880f-4f2b-baac-fd2dbfcd79c22
1729063selexipag 800 MCG Oral TabletSYff660787-880f-4f2b-baac-fd2dbfcd79c22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70771-1793-870771179308140 in 1 BOTTLEHistorical
70771-1796-67077117960660 in 1 BOTTLEHistorical
70771-1801-7707711801071 KIT in 1 CARTON (70771-1801-7) * 1 BOTTLE in 1 CARTON / 140 TABLET, FILM COATED in 1 BOTTLE (70771-1793-8) * 1 BOTTLE in 1 CARTON / 60 TABLET, FILM COATED in 1 BOTTLE (70771-1796-6) 1 kit2025-02-14NoNoHistorical