FDA.reportPublic FDA data

Orenitram

Product NDC
66302-362
11-digit product format
663020362
Labeler code
66302
Product ID
66302-362_bd66c62e-4aee-4fd0-bc7d-f78994dd9e29
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
treprostinil
Dosage form
KIT
Labeler
United Therapeutics Corporation
Application
NDA203496
Marketing category
NDA
Marketing start
2023-02-14
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N203496-001ORENITRAMTREPROSTINIL DIOLAMINEEQ 0.125MG BASETABLET, EXTENDED RELEASE / ORALRLD2013-12-20
N203496-002ORENITRAMTREPROSTINIL DIOLAMINEEQ 0.25MG BASETABLET, EXTENDED RELEASE / ORALRLD2013-12-20
N203496-003ORENITRAMTREPROSTINIL DIOLAMINEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALRLD, RS2013-12-20
N203496-004ORENITRAMTREPROSTINIL DIOLAMINEEQ 2.5MG BASETABLET, EXTENDED RELEASE / ORALRLD2013-12-20
N203496-005ORENITRAMTREPROSTINIL DIOLAMINEEQ 5MG BASETABLET, EXTENDED RELEASE / ORALRLD2016-10-07

Orange Book patents#

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N203496-00193932032026-04-27U-1877Drug product2016-07-22
N203496-00174170702026-07-30Drug substance2014-01-09
N203496-001117238872028-12-15Drug substance2023-08-15
N203496-00195930662028-12-15Drug substance2017-03-14
N203496-00196049012028-12-15Drug substance, Delist requested2017-03-28
N203496-00184101692030-02-13Drug product2014-01-09
N203496-00183498922031-01-22Drug product2014-01-09
N203496-00187478972031-08-11U-2725Drug product2014-06-13
N203496-00187478972031-08-11U-2724Drug product2014-06-13
N203496-00293932032026-04-27U-1877Drug product2016-07-22
N203496-00274170702026-07-30Drug substance2014-01-09
N203496-002117238872028-12-15Drug substance2023-08-15
N203496-00284973932028-12-15Drug substance, Delist requested2014-01-09
N203496-00295930662028-12-15Drug substance2017-03-14
N203496-00284101692030-02-13Drug product2014-01-09
N203496-00283498922031-01-22Drug product2014-01-09
N203496-00287478972031-08-11U-2725Drug product2014-06-13
N203496-00287478972031-08-11U-2724Drug product2014-06-13
N203496-00393932032026-04-27U-1877Drug product2016-07-22
N203496-00374170702026-07-30Drug substance2014-01-09
N203496-003117238872028-12-15Drug substance2023-08-15
N203496-00384973932028-12-15Drug substance, Delist requested2014-01-09
N203496-00395930662028-12-15Drug substance2017-03-14
N203496-00384101692030-02-13Drug product2014-01-09
N203496-00383498922031-01-22Drug product2014-01-09
N203496-00387478972031-08-11U-2725Drug product2014-06-13
N203496-00387478972031-08-11U-2724Drug product2014-06-13
N203496-00493932032026-04-27U-1877Drug product2016-07-22
N203496-00474170702026-07-30Drug substance2014-01-09
N203496-004117238872028-12-15Drug substance2023-08-15
N203496-00484973932028-12-15Drug substance, Delist requested2014-01-09
N203496-00495930662028-12-15Drug substance2017-03-14
N203496-00484101692030-02-13Drug product2014-01-09
N203496-00483498922031-01-22Drug product2014-01-09
N203496-00487478972031-08-11U-2724Drug product2014-06-13
N203496-00487478972031-08-11U-2725Drug product2014-06-13
N203496-00593932032026-04-27U-1877Drug product2017-02-09
N203496-00574170702026-07-30Drug substance2017-02-09
N203496-005117238872028-12-15Drug substance2023-08-15
N203496-00595930662028-12-15Drug substance2017-03-14
N203496-00596049012028-12-15Drug substance, Delist requested2017-03-28
N203496-00584101692030-02-13Drug product2017-02-09
N203496-00583498922031-01-22Drug product2017-02-09
N203496-00587478972031-08-11U-2725Drug product2017-02-09
N203496-00587478972031-08-11U-2724Drug product2017-02-09

Orange Book exclusivity#

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N203496-001ODE-2722026-10-18
N203496-002ODE-2722026-10-18
N203496-003ODE-2722026-10-18
N203496-004ODE-2722026-10-18
N203496-005ODE-2722026-10-18

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OrenitramTREPROSTINILUnited Therapeutics Corporation8ed2003a-c801-411e-831e-d06079bb0d7c2024-11-20Warnings, Adverse reactionsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings and cautions

5 WARNINGS AND PRECAUTIONS Do not abruptly discontinue dosing. ( 2.5 , 5.1 ) In patients with diverticulosis, Orenitram tablets can become lodged in a diverticulum. ( 5.2 ) 5.1 Worsening PAH Symptoms upon Abrupt Withdrawal Abrupt discontinuation or sudden large reductions in dosage of Orenitram may result in worsening of PAH symptoms. 5.2 Use in Patients with Blind-end Pouches The tablet shell does not dissolve. In patients with diverticulosis, Orenitram tablets can lodge in a diverticulum.

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

6 ADVERSE REACTIONS Most common adverse reactions (incidence >10%) reported in clinical studies in patients treated with Orenitram compared with placebo are headache, diarrhea, nausea, vomiting, jaw pain, and flushing. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact United Therapeutics Corp. at 1-866-458-6479 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In a 12-week, placebo-controlled, monotherapy study (Study 1; WHO Group 1; functional class II-III), and an event-driven, placebo-controlled, combination therapy study (Study 4; WHO Group 1; functional class I-III), the most commonly reported adverse reactions that occurred in patients receiving Orenitram included: headache, diarrhea, nausea, and flushing. Orenitram patients in Study 1 (N=151) had access to 0.25 mg tablets at randomization. Approximately 91% of such patients in Study 1 experienced an adverse reaction, but only 4% discontinued therapy for an adverse reaction (compared to 3% receiving placebo). Study 4 enrolled a total of 690 patients, 346 received Orenitram and 344 received placebo. Overall, 19% of patients treated with Orenitram discontinued treatment in Study 4 due to an adverse event (compared to 4% of patients receiving placebo). The exposure to Orenitram in Study 4 was up to 5.1 years with a median duration of exposure of 1.2 years. Table 1 summarizes adverse events with rates at least 5% higher on Orenitram therapy than on placebo that were reported in either Study 1 or 4. Table 1: Adverse Events with Rates at Least 5% Higher on Orenitram Therapy than on Placebo in Either Study 1 or Study 4 Reaction Study 1 N=228 Includes all subjects in the Primary Analysis Population Study 4 N=690 Orenitram n=151 Placebo n=77 Orenitram n=346 Placebo n=344 Headache 63% 19% 75% 35% Diarrhea 30% 16% 69% 29% Nausea 30% 18% 40% 23% Vomiting 17% 16% 36% 10% Flushing 15% 6% 45% 8% Pain in jaw 11% 4% 18% 3% Pain in extremity 14% 8% 18% 9% Hypokalemia 9% 3% 4% 3% Abdominal discomfort 6% 0% 8% 4% Upper abdominal pain 5% 3% 12% 5% Orenitram was studied in a long-term, open-label, extension study in w...

adverse reactions table

Table 1: Adverse Events with Rates at Least 5% Higher on Orenitram Therapy than on Placebo in Either Study 1 or Study 4ReactionStudy 1 N=228Includes all subjects in the Primary Analysis PopulationStudy 4 N=690Orenitram n=151Placebo n=77Orenitram n=346Placebo n=344Headache63%19%75%35%Diarrhea30%16%69%29%Nausea30%18%40%23%Vomiting17%16%36%10%Flushing15%6%45%8%Pain in jaw11%4%18%3%Pain in extremity14%8%18%9%Hypokalemia9%3%4%3%Abdominal discomfort6%0%8%4%Upper abdominal pain5%3%12%5%

Additional Listing Data#

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

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
66302-362-56Orenitram1 in 1 PACKAGEKIT124

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66302-362-56EA - Each66302-3620c44f6dd-1f21-47ce-860e-39f218b45f8d12023-03-13

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
66302-362ORENITRAM (TREPROSTINIL) TABLET, EXTENDED RELEASE ORENITRAM (TREPROSTINIL) KIT [UNITED THERAPEUTICS CORPORATION]24Current NDC, 1 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 startSampleExclude flagStatus
66302-362-56663020362561 KIT in 1 PACKAGE (66302-362-56) * 126 TABLET, EXTENDED RELEASE in 1 BLISTER PACK * 210 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 kit2023-02-14NoNoCurrent