VENTAVIS

Product NDC
66215-302
11-digit product format
662150302
Labeler code
66215
Product ID
66215-302_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
2005-05-07
Marketing end
0000-00-00
Substance
ILOPROST
Active strength
10 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct66215-302DDiscontinued by firm2026-08-17
excluded packagepackage66215-30266215-302-30DDiscontinued by firm2026-08-17

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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct66215-302DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66215-30266215-302-30DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021779-001VENTAVISILOPROST20MCG/2ML (10MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATION2004-12-29
N021779-002VENTAVISILOPROST10MCG/ML (10MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2005-12-08
N021779-003VENTAVISILOPROST20MCG/ML (20MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2009-08-07

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021779-001VENTAVIS20MCG/2ML (10MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATION2004-12-29caaa826d4ba7…
2026-08-18 06:07:402026-07N021779-002VENTAVIS10MCG/ML (10MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2005-12-08caaa826d4ba7…
2026-08-18 06:07:402026-07N021779-003VENTAVIS20MCG/ML (20MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2009-08-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021779-001VENTAVIS20MCG/2ML (10MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATION2004-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021779-002VENTAVIS10MCG/ML (10MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2005-12-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021779-003VENTAVIS20MCG/ML (20MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2009-08-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021779-001VENTAVIS20MCG/2ML (10MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATION2004-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021779-002VENTAVIS10MCG/ML (10MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2005-12-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021779-003VENTAVIS20MCG/ML (20MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2009-08-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N021779-001VENTAVIS20MCG/2ML (10MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATION2004-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021779-002VENTAVIS10MCG/ML (10MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2005-12-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021779-003VENTAVIS20MCG/ML (20MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2009-08-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021779-001VENTAVIS20MCG/2ML (10MCG/ML)SOLUTION / INHALATION2004-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021779-002VENTAVIS10MCG/ML (10MCG/ML)SOLUTION / INHALATIONRLD2005-12-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021779-003VENTAVIS20MCG/ML (20MCG/ML)SOLUTION / INHALATIONRLD2009-08-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021779-001VENTAVIS20MCG/2ML (10MCG/ML)SOLUTION / INHALATION2004-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021779-002VENTAVIS10MCG/ML (10MCG/ML)SOLUTION / INHALATIONRLD2005-12-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021779-003VENTAVIS20MCG/ML (20MCG/ML)SOLUTION / INHALATIONRLD2009-08-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021779-001VENTAVIS20MCG/2ML (10MCG/ML)SOLUTION / INHALATION2004-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021779-002VENTAVIS10MCG/ML (10MCG/ML)SOLUTION / INHALATIONRLD2005-12-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021779-003VENTAVIS20MCG/ML (20MCG/ML)SOLUTION / INHALATIONRLD2009-08-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021779-001VENTAVIS20MCG/2ML (10MCG/ML)SOLUTION / INHALATION2004-12-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021779-002VENTAVIS10MCG/ML (10MCG/ML)SOLUTION / INHALATIONRLD2005-12-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021779-003VENTAVIS20MCG/ML (20MCG/ML)SOLUTION / INHALATIONRLD2009-08-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021779-001VENTAVIS20MCG/2ML (10MCG/ML)SOLUTION / INHALATION2004-12-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021779-002VENTAVIS10MCG/ML (10MCG/ML)SOLUTION / INHALATIONRLD2005-12-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021779-003VENTAVIS20MCG/ML (20MCG/ML)SOLUTION / INHALATIONRLD2009-08-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021779-001VENTAVIS20MCG/2ML (10MCG/ML)SOLUTION / INHALATION2004-12-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021779-002VENTAVIS10MCG/ML (10MCG/ML)SOLUTION / INHALATIONRLD2005-12-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021779-003VENTAVIS20MCG/ML (20MCG/ML)SOLUTION / INHALATIONRLD2009-08-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021779-001VENTAVIS20MCG/2ML (10MCG/ML)SOLUTION / INHALATION2004-12-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N021779-002VENTAVIS10MCG/ML (10MCG/ML)SOLUTION / INHALATIONRLD2005-12-08d06236e962d9…
2024-10-29 15:01 UTC2024-10N021779-003VENTAVIS20MCG/ML (20MCG/ML)SOLUTION / INHALATIONRLD2009-08-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021779-001VENTAVIS20MCG/2ML (10MCG/ML)SOLUTION / INHALATION2004-12-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021779-002VENTAVIS10MCG/ML (10MCG/ML)SOLUTION / INHALATIONRLD2005-12-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021779-003VENTAVIS20MCG/ML (20MCG/ML)SOLUTION / INHALATIONRLD2009-08-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021779-001VENTAVIS20MCG/2ML (10MCG/ML)SOLUTION / INHALATION2004-12-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021779-002VENTAVIS10MCG/ML (10MCG/ML)SOLUTION / INHALATIONRLD2005-12-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021779-003VENTAVIS20MCG/ML (20MCG/ML)SOLUTION / INHALATIONRLD2009-08-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021779-001VENTAVIS20MCG/2ML (10MCG/ML)SOLUTION / INHALATION2004-12-291e350fbaab3a…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66215-302-00ML - Milliliter66215-302387cbf94-f42e-4ad8-8069-a33193aa6a6b12012-07-24
66215-302-30ML - Milliliter66215-30238929e1c-f5f7-4c0b-9fc6-81091af771a212012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66215-302VENTAVIS (ILOPROST) SOLUTION [ACTELION PHARMACEUTICALS US, INC.]24Legacy NDC20220729_d3bebc1c-f032-402a-bbc9-aff024276ed1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66215-302-306621503023030 AMPULE in 1 CARTON (66215-302-30) > 1 mL in 1 AMPULE (66215-302-00) 30 ampule2005-05-070000-00-00NoNoCurrent