FDA.reportPublic FDA data

UPTRAVI

Product NDC
66215-718
11-digit product format
662150718
Labeler code
66215
Product ID
66215-718_cf17e19e-ac3d-4787-88e8-f4cc7f4fcc74
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Selexipag
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Actelion Pharmaceuticals US, Inc.
Application
NDA214275
Marketing category
NDA
Marketing start
2021-07-29
Substance
SELEXIPAG
Active strength
1800 ug/10mL
Pharmacologic classes
Prostacyclin Receptor Agonist [EPC], Prostacyclin Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SELEXIPAG1800 ug/10mL

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
66215-718-01UPTRAVI10 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION1025
66215-718-01UPTRAVI1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION125

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66215-718-01EA - Each66215-7180bfd68d0-135d-4437-a80b-19529add251b12021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66215-718UPTRAVI (SELEXIPAG) TABLET, COATED UPTRAVI TITRATION PACK (SELEXIPAG) KIT UPTRAVI (SELEXIPAG) INJECTION, POWDER, FOR SOLUTION [ACTELION PHARMACEUTICALS US, INC.]24Current NDC, Legacy NDC, 2 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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
66215-718-01662150718011 VIAL, SINGLE-DOSE in 1 CARTON (66215-718-01) / 10 mL in 1 VIAL, SINGLE-DOSE2021-07-290000-00-00NoNoCurrent