FDA.reportPublic FDA data

Treprostinil

Product NDC
43598-649
11-digit product format
435980649
Labeler code
43598
Product ID
43598-649_61347918-bb33-236c-6a2e-280b59e7ab31
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Treprostinil
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Dr.Reddy's Laboratories Inc.,
Application
ANDA210214
Marketing category
ANDA
Marketing start
2023-02-13
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
43598-649-11Treprostinil1 in 1 CARTONINJECTION, SOLUTION18
43598-649-11Treprostinil20 mL in 1 VIALINJECTION, SOLUTION208

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-649-11ML - Milliliter43598-6498b910a7a-461a-45e6-aaa8-0f6379bac09b12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-649TREPROSTINIL INJECTION, SOLUTION STERILE DILUENT FOR TREPROSTINIL (WATER) INJECTION, SOLUTION [DR.REDDY'S LABORATORIES INC.,]8Current NDC, 2 package rows20240802_33050ee2-519b-1f0b-d4df-9e14dd329c57.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349407treprostinil 1 MG/ML Injectable SolutionPSN33050ee2-519b-1f0b-d4df-9e14dd329c578
349408treprostinil 10 MG/ML Injectable SolutionPSN33050ee2-519b-1f0b-d4df-9e14dd329c578
349409treprostinil 2.5 MG/ML Injectable SolutionPSN33050ee2-519b-1f0b-d4df-9e14dd329c578
349410treprostinil 5 MG/ML Injectable SolutionPSN33050ee2-519b-1f0b-d4df-9e14dd329c578
349407treprostinil 1 MG/ML Injectable SolutionSCD33050ee2-519b-1f0b-d4df-9e14dd329c578
349408treprostinil 10 MG/ML Injectable SolutionSCD33050ee2-519b-1f0b-d4df-9e14dd329c578
349409treprostinil 2.5 MG/ML Injectable SolutionSCD33050ee2-519b-1f0b-d4df-9e14dd329c578
349410treprostinil 5 MG/ML Injectable SolutionSCD33050ee2-519b-1f0b-d4df-9e14dd329c578

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43598-649-11435980649111 VIAL in 1 CARTON (43598-649-11) / 20 mL in 1 VIAL1 vial2023-02-13NoNoCurrent