FDA.reportPublic FDA data

Remodulin

Product NDC
66302-120
11-digit product format
663020120
Labeler code
66302
Product ID
66302-120_aeaf7f59-419a-4571-9839-7a1c576b1e73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
treprostinil
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
United Therapeutics Corporation
Application
NDA021272
Marketing category
NDA
Marketing start
2022-01-25
Marketing end
0000-00-00
Substance
TREPROSTINIL
Active strength
400 mg/20mL
Pharmacologic classes
Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d31d7280-9cbd-4e8c-ad8c-a830d9d6c4bfProduct name120260309
3a764347-294a-401b-979f-44c1c6bb101aProduct name120230126
5e14eefc-ad08-9fbf-a28c-67c518b16369Product name520210727
799cd7a2-692a-4730-993b-8b702e954a56Product name120200407
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66302-120-01Remodulin1 in 1 BOXINJECTION, SOLUTION133
66302-120-01Remodulin20 mL in 1 VIALINJECTION, SOLUTION2033

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
treprostinilACTIVE INGREDIENTRUM6K67ESGREMODULIN (TREPROSTINIL) INJECTION, SOLUTION [UNITED THERAPEUTICS CORPORATION]14
treprostinilACTIVE MOIETYRUM6K67ESGREMODULIN (TREPROSTINIL) INJECTION, SOLUTION [UNITED THERAPEUTICS CORPORATION]14
hydrochloric acidINACTIVE INGREDIENTQTT17582CBREMODULIN (TREPROSTINIL) INJECTION, SOLUTION [UNITED THERAPEUTICS CORPORATION]14
metacresolINACTIVE INGREDIENTGGO4Y809LOREMODULIN (TREPROSTINIL) INJECTION, SOLUTION [UNITED THERAPEUTICS CORPORATION]14
sodium chlorideINACTIVE INGREDIENT451W47IQ8XREMODULIN (TREPROSTINIL) INJECTION, SOLUTION [UNITED THERAPEUTICS CORPORATION]14
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRREMODULIN (TREPROSTINIL) INJECTION, SOLUTION [UNITED THERAPEUTICS CORPORATION]14
sodium hydroxideINACTIVE INGREDIENT55X04QC32IREMODULIN (TREPROSTINIL) INJECTION, SOLUTION [UNITED THERAPEUTICS CORPORATION]14
waterINACTIVE INGREDIENT059QF0KO0RREMODULIN (TREPROSTINIL) INJECTION, SOLUTION [UNITED THERAPEUTICS CORPORATION]14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66302-120REMODULIN (TREPROSTINIL) INJECTION, SOLUTION STERILE DILUENT FOR REMODULIN (WATER) INJECTION, SOLUTION [UNITED THERAPEUTICS CORPORATION]31Legacy NDC, 2 package rows20241213_6c80bb38-e8db-4138-9f0d-dbbf9c673185.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2667750Remodulin 0.1 MG/ML Injectable SolutionPSN6c80bb38-e8db-4138-9f0d-dbbf9c67318533
2667754Remodulin 0.2 MG/ML Injectable SolutionPSN6c80bb38-e8db-4138-9f0d-dbbf9c67318533
2667758Remodulin 0.4 MG/ML Injectable SolutionPSN6c80bb38-e8db-4138-9f0d-dbbf9c67318533
352211Remodulin 1 MG/ML Injectable SolutionPSN6c80bb38-e8db-4138-9f0d-dbbf9c67318533
352214Remodulin 10 MG/ML Injectable SolutionPSN6c80bb38-e8db-4138-9f0d-dbbf9c67318533
352212Remodulin 2.5 MG/ML Injectable SolutionPSN6c80bb38-e8db-4138-9f0d-dbbf9c67318533
2590177Remodulin 20 MG/ML Injectable SolutionPSN6c80bb38-e8db-4138-9f0d-dbbf9c67318533
352213Remodulin 5 MG/ML Injectable SolutionPSN6c80bb38-e8db-4138-9f0d-dbbf9c67318533
2667748treprostinil 0.1 MG/ML Injectable SolutionPSN6c80bb38-e8db-4138-9f0d-dbbf9c67318533
2667752treprostinil 0.2 MG/ML Injectable SolutionPSN6c80bb38-e8db-4138-9f0d-dbbf9c67318533
2667756treprostinil 0.4 MG/ML Injectable SolutionPSN6c80bb38-e8db-4138-9f0d-dbbf9c67318533
349407treprostinil 1 MG/ML Injectable SolutionPSN6c80bb38-e8db-4138-9f0d-dbbf9c67318533
349408treprostinil 10 MG/ML Injectable SolutionPSN6c80bb38-e8db-4138-9f0d-dbbf9c67318533
349409treprostinil 2.5 MG/ML Injectable SolutionPSN6c80bb38-e8db-4138-9f0d-dbbf9c67318533
2590175treprostinil 20 MG/ML Injectable SolutionPSN6c80bb38-e8db-4138-9f0d-dbbf9c67318533
349410treprostinil 5 MG/ML Injectable SolutionPSN6c80bb38-e8db-4138-9f0d-dbbf9c67318533
2667750treprostinil 0.1 MG/ML Injectable Solution [Remodulin]SBD6c80bb38-e8db-4138-9f0d-dbbf9c67318533
2667754treprostinil 0.2 MG/ML Injectable Solution [Remodulin]SBD6c80bb38-e8db-4138-9f0d-dbbf9c67318533
2667758treprostinil 0.4 MG/ML Injectable Solution [Remodulin]SBD6c80bb38-e8db-4138-9f0d-dbbf9c67318533
352211treprostinil 1 MG/ML Injectable Solution [Remodulin]SBD6c80bb38-e8db-4138-9f0d-dbbf9c67318533
352214treprostinil 10 MG/ML Injectable Solution [Remodulin]SBD6c80bb38-e8db-4138-9f0d-dbbf9c67318533
352212treprostinil 2.5 MG/ML Injectable Solution [Remodulin]SBD6c80bb38-e8db-4138-9f0d-dbbf9c67318533
2590177treprostinil 20 MG/ML Injectable Solution [Remodulin]SBD6c80bb38-e8db-4138-9f0d-dbbf9c67318533
352213treprostinil 5 MG/ML Injectable Solution [Remodulin]SBD6c80bb38-e8db-4138-9f0d-dbbf9c67318533
2667748treprostinil 0.1 MG/ML Injectable SolutionSCD6c80bb38-e8db-4138-9f0d-dbbf9c67318533
2667752treprostinil 0.2 MG/ML Injectable SolutionSCD6c80bb38-e8db-4138-9f0d-dbbf9c67318533
2667756treprostinil 0.4 MG/ML Injectable SolutionSCD6c80bb38-e8db-4138-9f0d-dbbf9c67318533
349407treprostinil 1 MG/ML Injectable SolutionSCD6c80bb38-e8db-4138-9f0d-dbbf9c67318533
349408treprostinil 10 MG/ML Injectable SolutionSCD6c80bb38-e8db-4138-9f0d-dbbf9c67318533
349409treprostinil 2.5 MG/ML Injectable SolutionSCD6c80bb38-e8db-4138-9f0d-dbbf9c67318533
2590175treprostinil 20 MG/ML Injectable SolutionSCD6c80bb38-e8db-4138-9f0d-dbbf9c67318533
349410treprostinil 5 MG/ML Injectable SolutionSCD6c80bb38-e8db-4138-9f0d-dbbf9c67318533
2667750Remodulin 0.1 MG/ML Injectable SolutionSY6c80bb38-e8db-4138-9f0d-dbbf9c67318533
2667754Remodulin 0.2 MG/ML Injectable SolutionSY6c80bb38-e8db-4138-9f0d-dbbf9c67318533
2667758Remodulin 0.4 MG/ML Injectable SolutionSY6c80bb38-e8db-4138-9f0d-dbbf9c67318533
352211Remodulin 1 MG/ML Injectable SolutionSY6c80bb38-e8db-4138-9f0d-dbbf9c67318533
352214Remodulin 10 MG/ML Injectable SolutionSY6c80bb38-e8db-4138-9f0d-dbbf9c67318533
352212Remodulin 2.5 MG/ML Injectable SolutionSY6c80bb38-e8db-4138-9f0d-dbbf9c67318533
2590177Remodulin 20 MG/ML Injectable SolutionSY6c80bb38-e8db-4138-9f0d-dbbf9c67318533
352213Remodulin 5 MG/ML Injectable SolutionSY6c80bb38-e8db-4138-9f0d-dbbf9c67318533

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66302-120-01663020120011 VIAL in 1 BOX (66302-120-01) > 20 mL in 1 VIAL1 vial2022-01-250000-00-00NoNoCurrent