FDA.reportPublic FDA data

Orenitram

Product NDC
66302-350
11-digit product format
663020350
Labeler code
66302
Product ID
66302-350_bd66c62e-4aee-4fd0-bc7d-f78994dd9e29
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
treprostinil
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
United Therapeutics Corporation
Application
NDA203496
Marketing category
NDA
Marketing start
2013-12-20
Substance
TREPROSTINIL
Active strength
5 mg/1
Pharmacologic classes
Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TREPROSTINIL5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRUM6K67ESG
Rxcui1488665, 1488667, 1488670, 1488671, 1488674, 1488675, 1488678, 1488679, 1858831, 1858833, 2630666, 2630667, 2630668, 2630669, 2630670, 2630671

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d31d7280-9cbd-4e8c-ad8c-a830d9d6c4bfProduct name120260309
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
3a764347-294a-401b-979f-44c1c6bb101aProduct name120230126
5e14eefc-ad08-9fbf-a28c-67c518b16369Product name520210727
799cd7a2-692a-4730-993b-8b702e954a56Product name120200407
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66302-350-01Orenitram100 in 1 BOTTLETABLET, EXTENDED RELEASE10024
66302-350-02Orenitram1 in 1 CARTONTABLET, EXTENDED RELEASE124
66302-350-02Orenitram10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1024
66302-350-10Orenitram10 in 1 BOTTLETABLET, EXTENDED RELEASE1024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66302-350-01EA - Each66302-350d10684b7-a5c3-4854-895e-f971283a2a6012017-07-07
66302-350-02EA - Each66302-350f4541683-d2d7-43f1-8191-cb6026f398b312023-03-13
66302-350-10EA - Each66302-3503ab1d5b6-2e06-43b0-9f3f-b96b6e2fc2f512017-07-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
treprostinilACTIVE INGREDIENTRUM6K67ESGORENITRAM (TREPROSTINIL) TABLET, EXTENDED RELEASE [UNITED THERAPEUTICS CORP.]5
treprostinilACTIVE MOIETYRUM6K67ESGORENITRAM (TREPROSTINIL) TABLET, EXTENDED RELEASE [UNITED THERAPEUTICS CORP.]5
AlcoholINACTIVE INGREDIENT3K9958V90MORENITRAM (TREPROSTINIL) TABLET, EXTENDED RELEASE [UNITED THERAPEUTICS CORP.]5
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3ORENITRAM (TREPROSTINIL) TABLET, EXTENDED RELEASE [UNITED THERAPEUTICS CORP.]5
Cellulose AcetateINACTIVE INGREDIENT3J2P07GVB6ORENITRAM (TREPROSTINIL) TABLET, EXTENDED RELEASE [UNITED THERAPEUTICS CORP.]5
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKORENITRAM (TREPROSTINIL) TABLET, EXTENDED RELEASE [UNITED THERAPEUTICS CORP.]5
Ferric Oxide RedINACTIVE INGREDIENT1K09F3G675ORENITRAM (TREPROSTINIL) TABLET, EXTENDED RELEASE [UNITED THERAPEUTICS CORP.]5
Ferric Oxide YellowINACTIVE INGREDIENTEX438O2MRTORENITRAM (TREPROSTINIL) TABLET, EXTENDED RELEASE [UNITED THERAPEUTICS CORP.]5
Ferrosoferric OxideINACTIVE INGREDIENTXM0M87F357ORENITRAM (TREPROSTINIL) TABLET, EXTENDED RELEASE [UNITED THERAPEUTICS CORP.]5
Isopropyl AlcoholINACTIVE INGREDIENTND2M416302ORENITRAM (TREPROSTINIL) TABLET, EXTENDED RELEASE [UNITED THERAPEUTICS CORP.]5
Magnesium StearateINACTIVE INGREDIENT70097M6I30ORENITRAM (TREPROSTINIL) TABLET, EXTENDED RELEASE [UNITED THERAPEUTICS CORP.]5
MaltodextrinINACTIVE INGREDIENT7CVR7L4A2DORENITRAM (TREPROSTINIL) TABLET, EXTENDED RELEASE [UNITED THERAPEUTICS CORP.]5
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PORENITRAM (TREPROSTINIL) TABLET, EXTENDED RELEASE [UNITED THERAPEUTICS CORP.]5
Polyvinyl alcoholINACTIVE INGREDIENT532B59J990ORENITRAM (TREPROSTINIL) TABLET, EXTENDED RELEASE [UNITED THERAPEUTICS CORP.]5
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3ORENITRAM (TREPROSTINIL) TABLET, EXTENDED RELEASE [UNITED THERAPEUTICS CORP.]5
ShellacINACTIVE INGREDIENT46N107B71OORENITRAM (TREPROSTINIL) TABLET, EXTENDED RELEASE [UNITED THERAPEUTICS CORP.]5
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JORENITRAM (TREPROSTINIL) TABLET, EXTENDED RELEASE [UNITED THERAPEUTICS CORP.]5
TalcINACTIVE INGREDIENT7SEV7J4R1UORENITRAM (TREPROSTINIL) TABLET, EXTENDED RELEASE [UNITED THERAPEUTICS CORP.]5
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPORENITRAM (TREPROSTINIL) TABLET, EXTENDED RELEASE [UNITED THERAPEUTICS CORP.]5
Triethyl CitrateINACTIVE INGREDIENT8Z96QXD6UMORENITRAM (TREPROSTINIL) TABLET, EXTENDED RELEASE [UNITED THERAPEUTICS CORP.]5
XylitolINACTIVE INGREDIENTVCQ006KQ1EORENITRAM (TREPROSTINIL) TABLET, EXTENDED RELEASE [UNITED THERAPEUTICS CORP.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66302-350ORENITRAM (TREPROSTINIL) TABLET, EXTENDED RELEASE ORENITRAM (TREPROSTINIL) KIT [UNITED THERAPEUTICS CORPORATION]24Current NDC, Legacy NDC, 4 package rows20241206_8ed2003a-c801-411e-831e-d06079bb0d7c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2630669{126 (12 HR treprostinil 0.125 MG Extended Release Oral Tablet [Orenitram]) / 210 (12 HR treprostinil 0.25 MG Extended Release Oral Tablet [Orenitram]) } Pack [Orenitram Month 2 Titration Kit]BPCK8ed2003a-c801-411e-831e-d06079bb0d7c24
2630667{126 (12 HR treprostinil 0.125 MG Extended Release Oral Tablet [Orenitram]) / 42 (12 HR treprostinil 0.25 MG Extended Release Oral Tablet [Orenitram]) } Pack [Orenitram Month 1 Titration Kit]BPCK8ed2003a-c801-411e-831e-d06079bb0d7c24
2630671{126 (12 HR treprostinil 0.125 MG Extended Release Oral Tablet [Orenitram]) / 42 (12 HR treprostinil 0.25 MG Extended Release Oral Tablet [Orenitram]) / 84 (12 HR treprostinil 1 MG Extended Release Oral Tablet [Orenitram]) } Pack [Orenitram Month 3 Titration Kit]BPCK8ed2003a-c801-411e-831e-d06079bb0d7c24
2630668{126 (12 HR treprostinil 0.125 MG Extended Release Oral Tablet) / 210 (12 HR treprostinil 0.25 MG Extended Release Oral Tablet) } PackGPCK8ed2003a-c801-411e-831e-d06079bb0d7c24
2630666{126 (12 HR treprostinil 0.125 MG Extended Release Oral Tablet) / 42 (12 HR treprostinil 0.25 MG Extended Release Oral Tablet) } PackGPCK8ed2003a-c801-411e-831e-d06079bb0d7c24
2630670{126 (12 HR treprostinil 0.125 MG Extended Release Oral Tablet) / 42 (12 HR treprostinil 0.25 MG Extended Release Oral Tablet) / 84 (12 HR treprostinil 1 MG Extended Release Oral Tablet) } PackGPCK8ed2003a-c801-411e-831e-d06079bb0d7c24
1488667Orenitram 0.125 MG 12HR Extended Release Oral TabletPSN8ed2003a-c801-411e-831e-d06079bb0d7c24
1488671Orenitram 0.25 MG 12HR Extended Release Oral TabletPSN8ed2003a-c801-411e-831e-d06079bb0d7c24
1488675Orenitram 1 MG 12HR Extended Release Oral TabletPSN8ed2003a-c801-411e-831e-d06079bb0d7c24
1488679Orenitram 2.5 MG 12HR Extended Release Oral TabletPSN8ed2003a-c801-411e-831e-d06079bb0d7c24
1858833Orenitram 5 MG 12HR Extended Release Oral TabletPSN8ed2003a-c801-411e-831e-d06079bb0d7c24
2630667Orenitram Month 1 Titration KitPSN8ed2003a-c801-411e-831e-d06079bb0d7c24
2630669Orenitram Month 2 Titration KitPSN8ed2003a-c801-411e-831e-d06079bb0d7c24
2630671Orenitram Month 3 Titration KitPSN8ed2003a-c801-411e-831e-d06079bb0d7c24
1488665treprostinil 0.125 MG 12HR Extended Release Oral TabletPSN8ed2003a-c801-411e-831e-d06079bb0d7c24
1488670treprostinil 0.25 MG 12HR Extended Release Oral TabletPSN8ed2003a-c801-411e-831e-d06079bb0d7c24
1488674treprostinil 1 MG 12HR Extended Release Oral TabletPSN8ed2003a-c801-411e-831e-d06079bb0d7c24
1488678treprostinil 2.5 MG 12HR Extended Release Oral TabletPSN8ed2003a-c801-411e-831e-d06079bb0d7c24
1858831treprostinil 5 MG 12HR Extended Release Oral TabletPSN8ed2003a-c801-411e-831e-d06079bb0d7c24
2630666treprostinil Oral Tablet Month 1 Titration KitPSN8ed2003a-c801-411e-831e-d06079bb0d7c24
2630668treprostinil Oral Tablet Month 2 Titration KitPSN8ed2003a-c801-411e-831e-d06079bb0d7c24
2630670treprostinil Oral Tablet Month 3 Titration KitPSN8ed2003a-c801-411e-831e-d06079bb0d7c24
148866712 HR treprostinil 0.125 MG Extended Release Oral Tablet [Orenitram]SBD8ed2003a-c801-411e-831e-d06079bb0d7c24
148867112 HR treprostinil 0.25 MG Extended Release Oral Tablet [Orenitram]SBD8ed2003a-c801-411e-831e-d06079bb0d7c24
148867512 HR treprostinil 1 MG Extended Release Oral Tablet [Orenitram]SBD8ed2003a-c801-411e-831e-d06079bb0d7c24
148867912 HR treprostinil 2.5 MG Extended Release Oral Tablet [Orenitram]SBD8ed2003a-c801-411e-831e-d06079bb0d7c24
185883312 HR treprostinil 5 MG Extended Release Oral Tablet [Orenitram]SBD8ed2003a-c801-411e-831e-d06079bb0d7c24
148866512 HR treprostinil 0.125 MG Extended Release Oral TabletSCD8ed2003a-c801-411e-831e-d06079bb0d7c24
148867012 HR treprostinil 0.25 MG Extended Release Oral TabletSCD8ed2003a-c801-411e-831e-d06079bb0d7c24
148867412 HR treprostinil 1 MG Extended Release Oral TabletSCD8ed2003a-c801-411e-831e-d06079bb0d7c24
148867812 HR treprostinil 2.5 MG Extended Release Oral TabletSCD8ed2003a-c801-411e-831e-d06079bb0d7c24
185883112 HR treprostinil 5 MG Extended Release Oral TabletSCD8ed2003a-c801-411e-831e-d06079bb0d7c24
148866712 HR Orenitram 0.125 MG Extended Release Oral TabletSY8ed2003a-c801-411e-831e-d06079bb0d7c24
148867112 HR Orenitram 0.25 MG Extended Release Oral TabletSY8ed2003a-c801-411e-831e-d06079bb0d7c24
148867512 HR Orenitram 1 MG Extended Release Oral TabletSY8ed2003a-c801-411e-831e-d06079bb0d7c24
148867912 HR Orenitram 2.5 MG Extended Release Oral TabletSY8ed2003a-c801-411e-831e-d06079bb0d7c24
185883312 HR Orenitram 5 MG Extended Release Oral TabletSY8ed2003a-c801-411e-831e-d06079bb0d7c24
1488667Orenitram 0.125 MG (as treprostinil diolamine 0.159 MG) 12 HR Extended Release Oral TabletSY8ed2003a-c801-411e-831e-d06079bb0d7c24
1488671Orenitram 0.25 MG (as treprostinil diolamine 0.317 MG) 12 HR Extended Release Oral TabletSY8ed2003a-c801-411e-831e-d06079bb0d7c24
1488675Orenitram 1 MG (as treprostinil diolamine 1.27 MG) 12 HR Extended Release Oral TabletSY8ed2003a-c801-411e-831e-d06079bb0d7c24
1488679Orenitram 2.5 MG (as treprostinil diolamine 3.17 MG) 12 HR Extended Release Oral TabletSY8ed2003a-c801-411e-831e-d06079bb0d7c24
1858833Orenitram 5 MG (as treprostinil diolamine 6.35 MG) 12 HR Extended Release Oral TabletSY8ed2003a-c801-411e-831e-d06079bb0d7c24
2630667Orenitram Month 1 Titration KitSY8ed2003a-c801-411e-831e-d06079bb0d7c24
2630669Orenitram Month 2 Titration KitSY8ed2003a-c801-411e-831e-d06079bb0d7c24
2630671Orenitram Month 3 Titration KitSY8ed2003a-c801-411e-831e-d06079bb0d7c24
1488665treprostinil 0.125 MG (as treprostinil diethanolamine) 12 HR Extended Release Oral TabletSY8ed2003a-c801-411e-831e-d06079bb0d7c24
1488665treprostinil 0.125 MG (as treprostinil diolamine 0.159 MG) 12 HR Extended Release Oral TabletSY8ed2003a-c801-411e-831e-d06079bb0d7c24
1488670treprostinil 0.25 MG (as treprostinil diethanolamine) 12 HR Extended Release Oral TabletSY8ed2003a-c801-411e-831e-d06079bb0d7c24
1488670treprostinil 0.25 MG (as treprostinil diolamine 0.317 MG) 12 HR Extended Release Oral TabletSY8ed2003a-c801-411e-831e-d06079bb0d7c24
1488674treprostinil 1 MG (as treprostinil diethanolamine) 12 HR Extended Release Oral TabletSY8ed2003a-c801-411e-831e-d06079bb0d7c24
1488674treprostinil 1 MG (as treprostinil diolamine 1.27 MG) 12 HR Extended Release Oral TabletSY8ed2003a-c801-411e-831e-d06079bb0d7c24
1488678treprostinil 2.5 MG (as treprostinil diethanolamine) 12 HR Extended Release Oral TabletSY8ed2003a-c801-411e-831e-d06079bb0d7c24
1488678treprostinil 2.5 MG (as treprostinil diolamine 3.17 MG) 12 HR Extended Release Oral TabletSY8ed2003a-c801-411e-831e-d06079bb0d7c24
1858831treprostinil 5 MG (as treprostinil diolamine 6.35 MG) 12 HR Extended Release Oral TabletSY8ed2003a-c801-411e-831e-d06079bb0d7c24
2630666treprostinil Oral Tablet Month 1 Titration KitSY8ed2003a-c801-411e-831e-d06079bb0d7c24
2630668treprostinil Oral Tablet Month 2 Titration KitSY8ed2003a-c801-411e-831e-d06079bb0d7c24
2630670treprostinil Oral Tablet Month 3 Titration KitSY8ed2003a-c801-411e-831e-d06079bb0d7c24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66302-350-0166302035001100 TABLET, EXTENDED RELEASE in 1 BOTTLE (66302-350-01) 2013-12-200000-00-00NoNoCurrent
66302-350-02663020350021 BLISTER PACK in 1 CARTON (66302-350-02) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2021-06-300000-00-00NoNoCurrent
66302-350-106630203501010 TABLET, EXTENDED RELEASE in 1 BOTTLE (66302-350-10) 2013-12-200000-00-00NoNoCurrent