treprostinil

Generic: treprostinil

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name treprostinil
Generic Name treprostinil
Labeler sandoz inc
Dosage Form INJECTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

treprostinil 50 mg/20mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-3425
Product ID 0781-3425_fe80d00e-9eba-4192-9515-f9a5ad686a53
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203649
Listing Expiration 2026-12-31
Marketing Start 2019-03-25

Pharmacologic Class

Established (EPC)
prostacycline vasodilator [epc]
Chemical Structure
prostaglandins i [cs]
Physiologic Effect
vasodilation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07813425
Hyphenated Format 0781-3425

Supplemental Identifiers

RxCUI
349407 349408 349409 349410
UNII
059QF0KO0R RUM6K67ESG
NUI
N0000175416 M0017817 N0000009909

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name treprostinil (source: ndc)
Generic Name treprostinil (source: ndc)
Application Number ANDA203649 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/20mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (0781-3425-80) / 20 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

0781-3425-80 1 VIAL, MULTI-DOSE in 1 CARTON (0781-3425-80) / 20 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

treprostinil (50 mg/20mL)

Linked Drug Pages (1)

Treprostinil, DILUENT ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "fe80d00e-9eba-4192-9515-f9a5ad686a53", "openfda": {"nui": ["N0000175416", "M0017817", "N0000009909"], "unii": ["059QF0KO0R", "RUM6K67ESG"], "rxcui": ["349407", "349408", "349409", "349410"], "spl_set_id": ["473297ca-a872-4052-a053-87dc8f0d3c13"], "pharm_class_cs": ["Prostaglandins I [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Prostacycline Vasodilator [EPC]"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (0781-3425-80)  / 20 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "0781-3425-80", "marketing_start_date": "20190325"}], "brand_name": "Treprostinil", "product_id": "0781-3425_fe80d00e-9eba-4192-9515-f9a5ad686a53", "dosage_form": "INJECTION", "pharm_class": ["Prostacycline Vasodilator [EPC]", "Prostaglandins I [CS]", "Vasodilation [PE]"], "product_ndc": "0781-3425", "generic_name": "treprostinil", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Treprostinil", "active_ingredients": [{"name": "TREPROSTINIL", "strength": "50 mg/20mL"}], "application_number": "ANDA203649", "marketing_category": "ANDA", "marketing_start_date": "20190325", "listing_expiration_date": "20261231"}