Home NDC 66215-403 Veletri
Product NDC 66215-403
11-digit product format 662150403
Labeler code 66215
Product ID 66215-403_39e8b7f8-f82a-4083-a284-ce571a87ce97
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name epoprostenol
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Actelion Pharmaceuticals US, Inc.
Application NDA022260
Marketing category NDA
Marketing start 2010-04-22
Substance EPOPROSTENOL
Active strength .5 mg/10mL
Pharmacologic classes Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022260-001 VELETRI EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 N022260-002 VELETRI EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD 2012-06-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022260-001 8598227 2027-02-02 N022260-001 8318802 2027-03-15 Drug product 2012-12-26 N022260-002 8598227 2027-02-02 N022260-002 8318802 2027-03-15 Drug product
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 3 · 84 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 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD 2012-06-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD 2012-06-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD 2012-06-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD 2012-06-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD 2012-06-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD 2012-06-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD 2012-06-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD 2012-06-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD 2012-06-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD 2012-06-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD 2012-06-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD 2012-06-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD 2012-06-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD 2012-06-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD 2012-06-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2012-06-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2012-06-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2012-06-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2008-06-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION RLD 2012-06-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2012-06-28 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 72 observed states.
Observed Orange Book patent history# Patent history page 1 of 5 · 168 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N022260-001 8598227 2027-02-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022260-001 8318802 2027-03-15 Drug product 2012-12-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022260-002 8598227 2027-02-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022260-002 8318802 2027-03-15 Drug product caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022260-001 8598227 2027-02-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022260-001 8318802 2027-03-15 Drug product 2012-12-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022260-002 8598227 2027-02-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022260-002 8318802 2027-03-15 Drug product 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022260-001 8598227 2027-02-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022260-001 8318802 2027-03-15 Drug product 2012-12-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022260-002 8598227 2027-02-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022260-002 8318802 2027-03-15 Drug product 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022260-001 8598227 2027-02-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022260-001 8318802 2027-03-15 Drug product 2012-12-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022260-002 8598227 2027-02-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022260-002 8318802 2027-03-15 Drug product 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022260-001 8598227 2027-02-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022260-001 8318802 2027-03-15 Drug product 2012-12-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022260-002 8598227 2027-02-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022260-002 8318802 2027-03-15 Drug product fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022260-001 8598227 2027-02-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022260-001 8318802 2027-03-15 Drug product 2012-12-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022260-002 8598227 2027-02-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022260-002 8318802 2027-03-15 Drug product b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022260-001 8598227 2027-02-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022260-001 8318802 2027-03-15 Drug product 2012-12-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022260-002 8598227 2027-02-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022260-002 8318802 2027-03-15 Drug product 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022260-001 8598227 2027-02-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022260-001 8318802 2027-03-15 Drug product 2012-12-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022260-002 8598227 2027-02-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022260-002 8318802 2027-03-15 Drug product 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022260-001 8598227 2027-02-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022260-001 8318802 2027-03-15 Drug product 2012-12-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022260-002 8598227 2027-02-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022260-002 8318802 2027-03-15 Drug product 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022260-001 8598227 2027-02-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022260-001 8318802 2027-03-15 Drug product 2012-12-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022260-002 8598227 2027-02-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022260-002 8318802 2027-03-15 Drug product d8e5a09893c0…
Additional Listing Data#
Finished product Yes
Brand name base Veletri
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EPOPROSTENOL .5 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination DCR9Z582X0 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 562501 Internal RxNorm lookup 562502 Internal RxNorm lookup 1009216 Internal RxNorm lookup 1302755 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66215-403-01 Veletri 10 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 10 15 66215-403-01 Veletri 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded epoprostenol ACTIVE INGREDIENT DCR9Z582X0 VELETRI (EPOPROSTENOL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTELION PHARMACEUTICALS US, INC.] 3 epoprostenol ACTIVE MOIETY DCR9Z582X0 VELETRI (EPOPROSTENOL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTELION PHARMACEUTICALS US, INC.] 3 arginine INACTIVE INGREDIENT 94ZLA3W45F VELETRI (EPOPROSTENOL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTELION PHARMACEUTICALS US, INC.] 3 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I VELETRI (EPOPROSTENOL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTELION PHARMACEUTICALS US, INC.] 3 sucrose INACTIVE INGREDIENT C151H8M554 VELETRI (EPOPROSTENOL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTELION PHARMACEUTICALS US, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66215-403 VELETRI (EPOPROSTENOL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTELION PHARMACEUTICALS US, INC.] 15 Current NDC, Legacy NDC, 2 package rows 20221130_df502787-46ec-4dd1-a2c0-be90f6d95a5d.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Veletri EPOPROSTENOL Actelion Pharmaceuticals US, Inc. df502787-46ec-4dd1-a2c0-be90f6d95a5d 2022-11-28 Warnings, Adverse reactions Exact identifier application applno (NDA): 022260 application number: NDA022260 ndc (product): 66215-403
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 66215-403-01 66215040301 1 VIAL in 1 CARTON (66215-403-01) / 10 mL in 1 VIAL 1 vial 2010-04-22 0000-00-00 No No Current