treprostinil

Generic: treprostinil

Labeler: dr.reddy's laboratories inc.,
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name treprostinil
Generic Name treprostinil
Labeler dr.reddy's laboratories inc.,
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

treprostinil 100 mg/20mL

Manufacturer
Dr.Reddy's Laboratories Inc.,

Identifiers & Regulatory

Product NDC 43598-647
Product ID 43598-647_61347918-bb33-236c-6a2e-280b59e7ab31
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210214
Listing Expiration 2026-12-31
Marketing Start 2023-02-13

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 43598647
Hyphenated Format 43598-647

Supplemental Identifiers

RxCUI
349407 349408 349409 349410
UPC
0343598126111
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 ANDA210214 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/20mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (43598-647-11) / 20 mL in 1 VIAL
source: ndc

Packages (1)

43598-647-11 1 VIAL in 1 CARTON (43598-647-11) / 20 mL in 1 VIAL

Ingredients (1)

treprostinil (100 mg/20mL)

Linked Drug Pages (1)

Sterile Diluent for Treprostinil, Treprostinil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "61347918-bb33-236c-6a2e-280b59e7ab31", "openfda": {"nui": ["N0000175416", "M0017817", "N0000009909"], "upc": ["0343598126111"], "unii": ["059QF0KO0R", "RUM6K67ESG"], "rxcui": ["349407", "349408", "349409", "349410"], "spl_set_id": ["33050ee2-519b-1f0b-d4df-9e14dd329c57"], "pharm_class_cs": ["Prostaglandins I [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Prostacycline Vasodilator [EPC]"], "manufacturer_name": ["Dr.Reddy's Laboratories Inc.,"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (43598-647-11)  / 20 mL in 1 VIAL", "package_ndc": "43598-647-11", "marketing_start_date": "20230213"}], "brand_name": "Treprostinil", "product_id": "43598-647_61347918-bb33-236c-6a2e-280b59e7ab31", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Prostacycline Vasodilator [EPC]", "Prostaglandins I [CS]", "Vasodilation [PE]"], "product_ndc": "43598-647", "generic_name": "Treprostinil", "labeler_name": "Dr.Reddy's Laboratories Inc.,", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Treprostinil", "active_ingredients": [{"name": "TREPROSTINIL", "strength": "100 mg/20mL"}], "application_number": "ANDA210214", "marketing_category": "ANDA", "marketing_start_date": "20230213", "listing_expiration_date": "20261231"}