treprostinil

Generic: treprostinil

Labeler: alembic pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name treprostinil
Generic Name treprostinil
Labeler alembic pharmaceuticals inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

treprostinil 50 mg/20mL

Manufacturer
Alembic Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 62332-515
Product ID 62332-515_5384ef7c-88cc-4ab7-8eb7-627eba752f9d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211574
Listing Expiration 2026-12-31
Marketing Start 2021-02-11

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 62332515
Hyphenated Format 62332-515

Supplemental Identifiers

RxCUI
349407 349408 349409 349410
UNII
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 ANDA211574 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/20mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (62332-515-20) / 20 mL in 1 VIAL
source: ndc

Packages (1)

62332-515-20 1 VIAL in 1 CARTON (62332-515-20) / 20 mL in 1 VIAL

Ingredients (1)

treprostinil (50 mg/20mL)

Linked Drug Pages (1)

Treprostinil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "5384ef7c-88cc-4ab7-8eb7-627eba752f9d", "openfda": {"nui": ["N0000175416", "M0017817", "N0000009909"], "unii": ["RUM6K67ESG"], "rxcui": ["349407", "349408", "349409", "349410"], "spl_set_id": ["4a684b13-669d-4721-8ed4-30cc7762b0b8"], "pharm_class_cs": ["Prostaglandins I [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Prostacycline Vasodilator [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (62332-515-20)  / 20 mL in 1 VIAL", "package_ndc": "62332-515-20", "marketing_start_date": "20210211"}], "brand_name": "Treprostinil", "product_id": "62332-515_5384ef7c-88cc-4ab7-8eb7-627eba752f9d", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Prostacycline Vasodilator [EPC]", "Prostaglandins I [CS]", "Vasodilation [PE]"], "product_ndc": "62332-515", "generic_name": "Treprostinil", "labeler_name": "Alembic Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Treprostinil", "active_ingredients": [{"name": "TREPROSTINIL", "strength": "50 mg/20mL"}], "application_number": "ANDA211574", "marketing_category": "ANDA", "marketing_start_date": "20210211", "listing_expiration_date": "20261231"}