FDA.reportPublic FDA data

UPTRAVI Titration Pack

Product NDC
66215-628
11-digit product format
662150628
Labeler code
66215
Product ID
66215-628_cf17e19e-ac3d-4787-88e8-f4cc7f4fcc74
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Selexipag
Dosage form
KIT
Labeler
Actelion Pharmaceuticals US, Inc.
Application
NDA207947
Marketing category
NDA
Marketing start
2015-12-21
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
UPTRAVI Titration Pack
Listing expiration
2027-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5EXC0E384L
Rxcui1729007, 1729013, 1729027, 1729029, 1729031, 1729033, 1729045, 1729047, 1729051, 1729053, 1729055, 1729057, 1729059, 1729061, 1729063, 1729065, 1729075, 1729076, 2565271, 2565275

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3940235d-2369-40fe-94e3-68f58494a1a8Product name320250627
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66215-628-20UPTRAVI Titration Pack1 in 1 CARTONKIT125

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66215-628-20EA - Each66215-628b3130a9c-938e-41b4-84ff-4535a9bde9e312016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66215-628UPTRAVI (SELEXIPAG) TABLET, COATED UPTRAVI TITRATION PACK (SELEXIPAG) KIT UPTRAVI (SELEXIPAG) INJECTION, POWDER, FOR SOLUTION [ACTELION PHARMACEUTICALS US, INC.]24Current NDC, Legacy NDC, 1 package rows20240709_a7a23b87-f892-4e2c-8e2e-ebf841220f90.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1729076{140 (selexipag 0.2 MG Oral Tablet [Uptravi]) / 60 (selexipag 0.8 MG Oral Tablet [Uptravi]) } Pack [Uptravi Titration Pack]BPCKa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729075{140 (selexipag 0.2 MG Oral Tablet) / 60 (selexipag 0.8 MG Oral Tablet) } PackGPCKa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729007selexipag 1000 MCG Oral TabletPSNa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729027selexipag 1200 MCG Oral TabletPSNa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729031selexipag 1400 MCG Oral TabletPSNa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729045selexipag 1600 MCG Oral TabletPSNa7a23b87-f892-4e2c-8e2e-ebf841220f9026
2565271selexipag 1800 MCG InjectionPSNa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729075selexipag 200 MCG (140), selexipag 800 MCG (60) Oral Tablet Titration PackPSNa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729051selexipag 200 MCG Oral TabletPSNa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729055selexipag 400 MCG Oral TabletPSNa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729059selexipag 600 MCG Oral TabletPSNa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729063selexipag 800 MCG Oral TabletPSNa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729013Uptravi 1000 MCG Oral TabletPSNa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729029Uptravi 1200 MCG Oral TabletPSNa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729033Uptravi 1400 MCG Oral TabletPSNa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729047Uptravi 1600 MCG Oral TabletPSNa7a23b87-f892-4e2c-8e2e-ebf841220f9026
2565275Uptravi 1800 MCG InjectionPSNa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729053Uptravi 200 MCG Oral TabletPSNa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729057Uptravi 400 MCG Oral TabletPSNa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729061Uptravi 600 MCG Oral TabletPSNa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729065Uptravi 800 MCG Oral TabletPSNa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729076Uptravi Titration PackPSNa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729053selexipag 0.2 MG Oral Tablet [Uptravi]SBDa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729057selexipag 0.4 MG Oral Tablet [Uptravi]SBDa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729061selexipag 0.6 MG Oral Tablet [Uptravi]SBDa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729065selexipag 0.8 MG Oral Tablet [Uptravi]SBDa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729013selexipag 1 MG Oral Tablet [Uptravi]SBDa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729029selexipag 1.2 MG Oral Tablet [Uptravi]SBDa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729033selexipag 1.4 MG Oral Tablet [Uptravi]SBDa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729047selexipag 1.6 MG Oral Tablet [Uptravi]SBDa7a23b87-f892-4e2c-8e2e-ebf841220f9026
2565275selexipag 1.8 MG Injection [Uptravi]SBDa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729051selexipag 0.2 MG Oral TabletSCDa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729055selexipag 0.4 MG Oral TabletSCDa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729059selexipag 0.6 MG Oral TabletSCDa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729063selexipag 0.8 MG Oral TabletSCDa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729007selexipag 1 MG Oral TabletSCDa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729027selexipag 1.2 MG Oral TabletSCDa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729031selexipag 1.4 MG Oral TabletSCDa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729045selexipag 1.6 MG Oral TabletSCDa7a23b87-f892-4e2c-8e2e-ebf841220f9026
2565271selexipag 1.8 MG InjectionSCDa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729076{140 (selexipag 200 MCG Oral Tablet [Uptravi]) / 60 (selexipag 800 MCG Oral Tablet [Uptravi]) } Pack [Uptravi Titration Pack]SYa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729075{140 (selexipag 200 MCG Oral Tablet) / 60 (selexipag 800 MCG Oral Tablet) } PackSYa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729007selexipag 1000 MCG Oral TabletSYa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729027selexipag 1200 MCG Oral TabletSYa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729031selexipag 1400 MCG Oral TabletSYa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729045selexipag 1600 MCG Oral TabletSYa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729051selexipag 200 MCG Oral TabletSYa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729055selexipag 400 MCG Oral TabletSYa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729059selexipag 600 MCG Oral TabletSYa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729063selexipag 800 MCG Oral TabletSYa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729053Uptravi 0.2 MG Oral TabletSYa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729057Uptravi 0.4 MG Oral TabletSYa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729061Uptravi 0.6 MG Oral TabletSYa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729065Uptravi 0.8 MG Oral TabletSYa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729013Uptravi 1 MG Oral TabletSYa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729029Uptravi 1.2 MG Oral TabletSYa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729033Uptravi 1.4 MG Oral TabletSYa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729047Uptravi 1.6 MG Oral TabletSYa7a23b87-f892-4e2c-8e2e-ebf841220f9026
2565275Uptravi 1.8 MG InjectionSYa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729013Uptravi 1000 MCG Oral TabletSYa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729029Uptravi 1200 MCG Oral TabletSYa7a23b87-f892-4e2c-8e2e-ebf841220f9026
2565275Uptravi 1800 MCG InjectionSYa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729053Uptravi 200 MCG Oral TabletSYa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729057Uptravi 400 MCG Oral TabletSYa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729061Uptravi 600 MCG Oral TabletSYa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729065Uptravi 800 MCG Oral TabletSYa7a23b87-f892-4e2c-8e2e-ebf841220f9026
1729076Uptravi Titration PackSYa7a23b87-f892-4e2c-8e2e-ebf841220f9026

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66215-628-20662150628201 KIT in 1 CARTON (66215-628-20) * 1 BOTTLE in 1 CARTON / 140 TABLET, COATED in 1 BOTTLE * 1 BOTTLE in 1 CARTON / 60 TABLET, COATED in 1 BOTTLE1 kit2015-12-210000-00-00NoNoCurrent