aurlumyn

Generic: iloprost

Labeler: btg international inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name aurlumyn
Generic Name iloprost
Labeler btg international inc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

iloprost 100 ug/mL

Manufacturer
BTG International Inc

Identifiers & Regulatory

Product NDC 50633-340
Product ID 50633-340_445e0469-117b-0ed5-e063-6394a90abe40
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA217933
Listing Expiration 2026-12-31
Marketing Start 2025-08-01

Pharmacologic Class

Established (EPC)
prostacycline [epc]
Chemical Structure
prostaglandins i [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50633340
Hyphenated Format 50633-340

Supplemental Identifiers

RxCUI
2680303 2680309
UNII
JED5K35YGL
NUI
N0000175603 M0017817

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 aurlumyn (source: ndc)
Generic Name iloprost (source: ndc)
Application Number NDA217933 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 ug/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (50633-340-01) / 1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

50633-340-01 1 VIAL, SINGLE-DOSE in 1 CARTON (50633-340-01) / 1 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

iloprost (100 ug/mL)

Linked Drug Pages (1)

AURLUMYN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "445e0469-117b-0ed5-e063-6394a90abe40", "openfda": {"nui": ["N0000175603", "M0017817"], "unii": ["JED5K35YGL"], "rxcui": ["2680303", "2680309"], "spl_set_id": ["34036fc0-6832-d066-e063-6394a90a18a4"], "pharm_class_cs": ["Prostaglandins I [CS]"], "pharm_class_epc": ["Prostacycline [EPC]"], "manufacturer_name": ["BTG International Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (50633-340-01)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "50633-340-01", "marketing_start_date": "20250801"}], "brand_name": "AURLUMYN", "product_id": "50633-340_445e0469-117b-0ed5-e063-6394a90abe40", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Prostacycline [EPC]", "Prostaglandins I [CS]"], "product_ndc": "50633-340", "generic_name": "ILOPROST", "labeler_name": "BTG International Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AURLUMYN", "active_ingredients": [{"name": "ILOPROST", "strength": "100 ug/mL"}], "application_number": "NDA217933", "marketing_category": "NDA", "marketing_start_date": "20250801", "listing_expiration_date": "20261231"}