FDA.reportPublic FDA data

Treprostinil

Product NDC
0781-3420
11-digit product format
007813420
Labeler code
0781
Product ID
0781-3420_fe80d00e-9eba-4192-9515-f9a5ad686a53
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
treprostinil
Dosage form
INJECTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Sandoz Inc
Application
ANDA203649
Marketing category
ANDA
Marketing start
2019-03-25
Substance
TREPROSTINIL
Active strength
20 mg/20mL
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
Treprostinil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TREPROSTINIL20 mg/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRUM6K67ESG, 059QF0KO0R
Rxcui349407, 349408, 349409, 349410

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
0781-3420-80Treprostinil1 in 1 CARTONINJECTION125
0781-3420-80Treprostinil20 mL in 1 VIAL, MULTI-DOSEINJECTION2025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3420-80ML - Milliliter0781-34208c054ac5-5e40-495e-b2aa-bae2aaffe5a312019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3420TREPROSTINIL INJECTION DILUENT (WATER SOLUTION) INJECTION [SANDOZ INC]25Current NDC, Legacy NDC, 2 package rows20230913_473297ca-a872-4052-a053-87dc8f0d3c13.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349407treprostinil 1 MG/ML Injectable SolutionPSN473297ca-a872-4052-a053-87dc8f0d3c1325
349408treprostinil 10 MG/ML Injectable SolutionPSN473297ca-a872-4052-a053-87dc8f0d3c1325
349409treprostinil 2.5 MG/ML Injectable SolutionPSN473297ca-a872-4052-a053-87dc8f0d3c1325
349410treprostinil 5 MG/ML Injectable SolutionPSN473297ca-a872-4052-a053-87dc8f0d3c1325
349407treprostinil 1 MG/ML Injectable SolutionSCD473297ca-a872-4052-a053-87dc8f0d3c1325
349408treprostinil 10 MG/ML Injectable SolutionSCD473297ca-a872-4052-a053-87dc8f0d3c1325
349409treprostinil 2.5 MG/ML Injectable SolutionSCD473297ca-a872-4052-a053-87dc8f0d3c1325
349410treprostinil 5 MG/ML Injectable SolutionSCD473297ca-a872-4052-a053-87dc8f0d3c1325

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-3420-80007813420801 VIAL, MULTI-DOSE in 1 CARTON (0781-3420-80) / 20 mL in 1 VIAL, MULTI-DOSE2019-03-250000-00-00NoNoCurrent