Home NDC 66215-303 VENTAVIS
Product NDC 66215-303
11-digit product format 662150303
Labeler code 66215
Product ID 66215-303_431e95f6-7248-48e7-a836-3e43c7295229
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name iloprost
Dosage form SOLUTION
Route RESPIRATORY (INHALATION)
Labeler Actelion Pharmaceuticals US, Inc.
Application NDA021779
Marketing category NDA
Marketing start 2009-08-24
Marketing end 0000-00-00
Substance ILOPROST
Active strength 20 ug/mL
Pharmacologic classes Prostacycline [EPC], Prostaglandins I [CS]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 66215-303 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 66215-303 66215-303-30 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021779-001 VENTAVIS ILOPROST 20MCG/2ML (10MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INHALATION 2004-12-29 N021779-002 VENTAVIS ILOPROST 10MCG/ML (10MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INHALATION RLD 2005-12-08 N021779-003 VENTAVIS ILOPROST 20MCG/ML (20MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INHALATION RLD 2009-08-07
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 4 · 126 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N021779-001 VENTAVIS 20MCG/2ML (10MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INHALATION 2004-12-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021779-002 VENTAVIS 10MCG/ML (10MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INHALATION RLD 2005-12-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021779-003 VENTAVIS 20MCG/ML (20MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INHALATION RLD 2009-08-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021779-001 VENTAVIS 20MCG/2ML (10MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INHALATION 2004-12-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021779-002 VENTAVIS 10MCG/ML (10MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INHALATION RLD 2005-12-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021779-003 VENTAVIS 20MCG/ML (20MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INHALATION RLD 2009-08-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021779-001 VENTAVIS 20MCG/2ML (10MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INHALATION 2004-12-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021779-002 VENTAVIS 10MCG/ML (10MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INHALATION RLD 2005-12-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021779-003 VENTAVIS 20MCG/ML (20MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INHALATION RLD 2009-08-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021779-001 VENTAVIS 20MCG/2ML (10MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INHALATION 2004-12-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021779-002 VENTAVIS 10MCG/ML (10MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INHALATION RLD 2005-12-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021779-003 VENTAVIS 20MCG/ML (20MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INHALATION RLD 2009-08-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021779-001 VENTAVIS 20MCG/2ML (10MCG/ML) SOLUTION / INHALATION 2004-12-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021779-002 VENTAVIS 10MCG/ML (10MCG/ML) SOLUTION / INHALATION RLD 2005-12-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021779-003 VENTAVIS 20MCG/ML (20MCG/ML) SOLUTION / INHALATION RLD 2009-08-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021779-001 VENTAVIS 20MCG/2ML (10MCG/ML) SOLUTION / INHALATION 2004-12-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021779-002 VENTAVIS 10MCG/ML (10MCG/ML) SOLUTION / INHALATION RLD 2005-12-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021779-003 VENTAVIS 20MCG/ML (20MCG/ML) SOLUTION / INHALATION RLD 2009-08-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021779-001 VENTAVIS 20MCG/2ML (10MCG/ML) SOLUTION / INHALATION 2004-12-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021779-002 VENTAVIS 10MCG/ML (10MCG/ML) SOLUTION / INHALATION RLD 2005-12-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021779-003 VENTAVIS 20MCG/ML (20MCG/ML) SOLUTION / INHALATION RLD 2009-08-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021779-001 VENTAVIS 20MCG/2ML (10MCG/ML) SOLUTION / INHALATION 2004-12-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021779-002 VENTAVIS 10MCG/ML (10MCG/ML) SOLUTION / INHALATION RLD 2005-12-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021779-003 VENTAVIS 20MCG/ML (20MCG/ML) SOLUTION / INHALATION RLD 2009-08-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021779-001 VENTAVIS 20MCG/2ML (10MCG/ML) SOLUTION / INHALATION 2004-12-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021779-002 VENTAVIS 10MCG/ML (10MCG/ML) SOLUTION / INHALATION RLD 2005-12-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021779-003 VENTAVIS 20MCG/ML (20MCG/ML) SOLUTION / INHALATION RLD 2009-08-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021779-001 VENTAVIS 20MCG/2ML (10MCG/ML) SOLUTION / INHALATION 2004-12-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021779-002 VENTAVIS 10MCG/ML (10MCG/ML) SOLUTION / INHALATION RLD 2005-12-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021779-003 VENTAVIS 20MCG/ML (20MCG/ML) SOLUTION / INHALATION RLD 2009-08-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021779-001 VENTAVIS 20MCG/2ML (10MCG/ML) SOLUTION / INHALATION 2004-12-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021779-002 VENTAVIS 10MCG/ML (10MCG/ML) SOLUTION / INHALATION RLD 2005-12-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021779-003 VENTAVIS 20MCG/ML (20MCG/ML) SOLUTION / INHALATION RLD 2009-08-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021779-001 VENTAVIS 20MCG/2ML (10MCG/ML) SOLUTION / INHALATION 2004-12-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021779-002 VENTAVIS 10MCG/ML (10MCG/ML) SOLUTION / INHALATION RLD 2005-12-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021779-003 VENTAVIS 20MCG/ML (20MCG/ML) SOLUTION / INHALATION RLD 2009-08-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021779-001 VENTAVIS 20MCG/2ML (10MCG/ML) SOLUTION / INHALATION 2004-12-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021779-002 VENTAVIS 10MCG/ML (10MCG/ML) SOLUTION / INHALATION RLD 2005-12-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021779-003 VENTAVIS 20MCG/ML (20MCG/ML) SOLUTION / INHALATION RLD 2009-08-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021779-001 VENTAVIS 20MCG/2ML (10MCG/ML) SOLUTION / INHALATION 2004-12-29 1e350fbaab3a…
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66215-303 VENTAVIS (ILOPROST) SOLUTION [ACTELION PHARMACEUTICALS US, INC.] 24 Legacy NDC 20220729_d3bebc1c-f032-402a-bbc9-aff024276ed1.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 66215-303-30 66215030330 30 AMPULE in 1 CARTON (66215-303-30) > 1 mL in 1 AMPULE (66215-303-00) 30 ampule 2009-08-24 0000-00-00 No No Current